Trial Outcomes & Findings for Open-Label Proof of Concept Study of VP-315 in Basal Cell Carcinoma (NCT NCT05188729)
NCT ID: NCT05188729
Last Updated: 2025-06-18
Results Overview
Part 1: Percentage of subjects that discontinued the study due to adverse event
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
Up to 9 weeks
Results posted on
2025-06-18
Participant Flow
Recruitment Details Study participants were recruited from one of the clinical trial sites selected to participate in the trial that met the study criteria and expressed interest in participating in a BCC trial. Up to 2 Target Lesions for treatment could be enrolled for each participant.
Unit of analysis: Target Lesion
Participant milestones
| Measure |
Part 1 - Cohort 1 - Intra-subject Dose Escalation
2 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 2 - Intra-subject Dose Escalation
3 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 3 mg on Day 1, 4 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 3 - Intra-subject Dose Escalation
4 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 4 mg on Day 1, 5 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 4 - Intra-subject Dose Escalation
5 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 5 mg on Day 1, 6 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 5 - Intra-subject Dose Escalation
6 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 6 mg on Day 1, 7 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 Cohort 6 - Intra-subject Dose Escalation
7 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 7 mg on Day 1, 8 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 7 - Intra-subject Dose Escalation
8 mg VP-315 starting dose. Subjects will receive once daily doses of 8 mg for up to 3 days in a 7-day treatment week (e.g., 8 mg on Day 1, 8 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose
VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1 1
|
1 1
|
1 1
|
1 1
|
1 1
|
1 1
|
6 6
|
6 7
|
3 3
|
10 11
|
26 31
|
10 12
|
27 34
|
|
Overall Study
COMPLETED
|
1 1
|
1 1
|
1 1
|
1 1
|
1 1
|
1 1
|
6 6
|
6 7
|
3 3
|
9 10
|
25 30
|
9 10
|
27 34
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
1 1
|
1 1
|
1 2
|
0 0
|
Reasons for withdrawal
| Measure |
Part 1 - Cohort 1 - Intra-subject Dose Escalation
2 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 2 - Intra-subject Dose Escalation
3 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 3 mg on Day 1, 4 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 3 - Intra-subject Dose Escalation
4 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 4 mg on Day 1, 5 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 4 - Intra-subject Dose Escalation
5 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 5 mg on Day 1, 6 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 5 - Intra-subject Dose Escalation
6 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 6 mg on Day 1, 7 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 Cohort 6 - Intra-subject Dose Escalation
7 mg VP-315 starting dose. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 7 mg on Day 1, 8 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 1 - Cohort 7 - Intra-subject Dose Escalation
8 mg VP-315 starting dose. Subjects will receive once daily doses of 8 mg for up to 3 days in a 7-day treatment week (e.g., 8 mg on Day 1, 8 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
|
Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose
VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Data reported for Target Lesion 1
Baseline characteristics by cohort
| Measure |
Part 1 - All Cohorts
n=12 Target Lesions
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose
n=7 Target Lesions
VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 Target Lesions
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=11 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=31 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=12 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=34 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Total
n=110 Target Lesions
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 7.97 • n=10 Participants
|
63.7 years
STANDARD_DEVIATION 13.82 • n=6 Participants
|
65.0 years
STANDARD_DEVIATION 6.08 • n=3 Participants
|
60.4 years
STANDARD_DEVIATION 10.09 • n=10 Participants
|
66.3 years
STANDARD_DEVIATION 9.22 • n=26 Participants
|
68.3 years
STANDARD_DEVIATION 10.59 • n=10 Participants
|
64.2 years
STANDARD_DEVIATION 9.35 • n=27 Participants
|
64.7 years
STANDARD_DEVIATION 9.57 • n=92 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=10 Participants
|
16 Participants
n=26 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=27 Participants
|
44 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=10 Participants
|
10 Participants
n=26 Participants
|
5 Participants
n=10 Participants
|
16 Participants
n=27 Participants
|
48 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=10 Participants
|
25 Participants
n=26 Participants
|
10 Participants
n=10 Participants
|
26 Participants
n=27 Participants
|
90 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=92 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
9 Participants
n=10 Participants
|
26 Participants
n=26 Participants
|
10 Participants
n=10 Participants
|
27 Participants
n=27 Participants
|
91 Participants
n=92 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=92 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
6 participants
n=6 Participants
|
3 participants
n=3 Participants
|
10 participants
n=10 Participants
|
26 participants
n=26 Participants
|
10 participants
n=10 Participants
|
27 participants
n=27 Participants
|
92 participants
n=92 Participants
|
|
Fitzpatrick Skin Type
I
|
3 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=27 Participants
|
13 Participants
n=92 Participants
|
|
Fitzpatrick Skin Type
II
|
4 Participants
n=10 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=10 Participants
|
20 Participants
n=26 Participants
|
5 Participants
n=10 Participants
|
17 Participants
n=27 Participants
|
61 Participants
n=92 Participants
|
|
Fitzpatrick Skin Type
III
|
3 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=26 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=27 Participants
|
17 Participants
n=92 Participants
|
|
Fitzpatrick Skin Type
IV
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=92 Participants
|
|
Fitzpatrick Skin Type
V
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=92 Participants
|
|
Fitzpatrick Skin Type
VI
|
0 Participants
n=10 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=92 Participants
|
|
Target Lesion 01 - Screening Histologic Result
Micronodular
|
0 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
0 Target Lesions
n=6 Target Lesions • Data reported for Target Lesion 1
|
0 Target Lesions
n=3 Target Lesions • Data reported for Target Lesion 1
|
0 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
0 Target Lesions
n=26 Target Lesions • Data reported for Target Lesion 1
|
0 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
0 Target Lesions
n=27 Target Lesions • Data reported for Target Lesion 1
|
0 Target Lesions
n=92 Target Lesions • Data reported for Target Lesion 1
|
|
Target Lesion 01 - Screening Histologic Result
Nodular
|
4 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
1 Target Lesions
n=6 Target Lesions • Data reported for Target Lesion 1
|
0 Target Lesions
n=3 Target Lesions • Data reported for Target Lesion 1
|
4 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
15 Target Lesions
n=26 Target Lesions • Data reported for Target Lesion 1
|
6 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
15 Target Lesions
n=27 Target Lesions • Data reported for Target Lesion 1
|
45 Target Lesions
n=92 Target Lesions • Data reported for Target Lesion 1
|
|
Target Lesion 01 - Screening Histologic Result
Superficial
|
6 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
5 Target Lesions
n=6 Target Lesions • Data reported for Target Lesion 1
|
3 Target Lesions
n=3 Target Lesions • Data reported for Target Lesion 1
|
6 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
11 Target Lesions
n=26 Target Lesions • Data reported for Target Lesion 1
|
4 Target Lesions
n=10 Target Lesions • Data reported for Target Lesion 1
|
12 Target Lesions
n=27 Target Lesions • Data reported for Target Lesion 1
|
47 Target Lesions
n=92 Target Lesions • Data reported for Target Lesion 1
|
|
Target Lesion 02 - Screening Histologic Result
Micronodular
|
0 Target Lesions
n=2 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
n=1 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
n=1 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
n=5 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
n=2 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
n=7 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
n=18 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
|
Target Lesion 02 - Screening Histologic Result
Nodular
|
2 Target Lesions
n=2 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
n=1 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
1 Target Lesions
n=1 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
1 Target Lesions
n=5 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
1 Target Lesions
n=2 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
3 Target Lesions
n=7 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
8 Target Lesions
n=18 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
|
Target Lesion 02 - Screening Histologic Result
Superficial
|
0 Target Lesions
n=2 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
1 Target Lesions
n=1 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
0 Target Lesions
n=1 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
4 Target Lesions
n=5 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
1 Target Lesions
n=2 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
4 Target Lesions
n=7 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
10 Target Lesions
n=18 Target Lesions • Target lesion 2 data reported. Number analyzed reflects the participants who had 2 lesions assigned to interventions.
|
|
Target Lesion 01 - Screening BCC Location
Face or Neck
|
1 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=6 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=3 Target Lesions • Target lesion 01 data reported.
|
1 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
4 Target Lesions
n=26 Target Lesions • Target lesion 01 data reported.
|
1 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
4 Target Lesions
n=27 Target Lesions • Target lesion 01 data reported.
|
11 Target Lesions
n=92 Target Lesions • Target lesion 01 data reported.
|
|
Target Lesion 01 - Screening BCC Location
Clavicle or Shoulder
|
1 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=6 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=3 Target Lesions • Target lesion 01 data reported.
|
2 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
5 Target Lesions
n=26 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
4 Target Lesions
n=27 Target Lesions • Target lesion 01 data reported.
|
12 Target Lesions
n=92 Target Lesions • Target lesion 01 data reported.
|
|
Target Lesion 01 - Screening BCC Location
Arm
|
2 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
1 Target Lesions
n=6 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=3 Target Lesions • Target lesion 01 data reported.
|
2 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
7 Target Lesions
n=26 Target Lesions • Target lesion 01 data reported.
|
3 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
4 Target Lesions
n=27 Target Lesions • Target lesion 01 data reported.
|
19 Target Lesions
n=92 Target Lesions • Target lesion 01 data reported.
|
|
Target Lesion 01 - Screening BCC Location
Chest or Abdomen
|
1 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=6 Target Lesions • Target lesion 01 data reported.
|
3 Target Lesions
n=3 Target Lesions • Target lesion 01 data reported.
|
2 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
5 Target Lesions
n=26 Target Lesions • Target lesion 01 data reported.
|
1 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
3 Target Lesions
n=27 Target Lesions • Target lesion 01 data reported.
|
15 Target Lesions
n=92 Target Lesions • Target lesion 01 data reported.
|
|
Target Lesion 01 - Screening BCC Location
Back
|
5 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
4 Target Lesions
n=6 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=3 Target Lesions • Target lesion 01 data reported.
|
3 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
4 Target Lesions
n=26 Target Lesions • Target lesion 01 data reported.
|
3 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
9 Target Lesions
n=27 Target Lesions • Target lesion 01 data reported.
|
28 Target Lesions
n=92 Target Lesions • Target lesion 01 data reported.
|
|
Target Lesion 01 - Screening BCC Location
Buttock or Groin
|
0 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=6 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=3 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=26 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=27 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=92 Target Lesions • Target lesion 01 data reported.
|
|
Target Lesion 01 - Screening BCC Location
Leg or Foot
|
0 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
1 Target Lesions
n=6 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=3 Target Lesions • Target lesion 01 data reported.
|
0 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
1 Target Lesions
n=26 Target Lesions • Target lesion 01 data reported.
|
2 Target Lesions
n=10 Target Lesions • Target lesion 01 data reported.
|
3 Target Lesions
n=27 Target Lesions • Target lesion 01 data reported.
|
7 Target Lesions
n=92 Target Lesions • Target lesion 01 data reported.
|
|
Target Lesion 02 - Screening BCC Location
Face or Neck
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=5 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
1 Target Lesions
n=7 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
1 Target Lesions
n=18 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
|
Target Lesion 02 - Screening BCC Location
Clavicle or Shoulder
|
1 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
2 Target Lesions
n=5 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
1 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
1 Target Lesions
n=7 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
5 Target Lesions
n=18 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
|
Target Lesion 02 - Screening BCC Location
Arm
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
1 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
1 Target Lesions
n=5 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
1 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=7 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
3 Target Lesions
n=18 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
|
Target Lesion 02 - Screening BCC Location
Chest or Abdomen
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
2 Target Lesions
n=5 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
3 Target Lesions
n=7 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
5 Target Lesions
n=18 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
|
Target Lesion 02 - Screening BCC Location
Back
|
1 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
1 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=5 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
2 Target Lesions
n=7 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
4 Target Lesions
n=18 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
|
Target Lesion 02 - Screening BCC Location
Buttocks or Groin
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=5 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=7 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=18 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
|
Target Lesion 02 - Screening BCC Location
Leg or Foot
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=1 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=5 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=2 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=7 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
0 Target Lesions
n=18 Target Lesions • Target Lesion 02 data reported for participants who had a second lesion assigned to treatment.
|
PRIMARY outcome
Timeframe: Up to 9 weeksPopulation: Part 1 - Enrolled Subjects. Due to the small number of subjects in each Cohort for Part 1, data for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
Part 1: Percentage of subjects that discontinued the study due to adverse event
Outcome measures
| Measure |
Part 1 - All Cohorts
n=10 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 1: Percentage of Subjects With Discontinuations Due to Adverse Events
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 4 (Safety Assessment)Population: Safety Population - Part 1 only. Due to the small number of subjects in each Cohort for Part 1, data for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
Subjects with pre-determined dose-limiting toxicities such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)
Outcome measures
| Measure |
Part 1 - All Cohorts
n=10 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 1: Percentage of Subjects With Dose-limiting Toxicities (DLTs)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 9 weeksPopulation: Safety Population. Due to the small number of subjects in each Cohort for Part 1, data for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
Cutaneous injection site reactions are defined as the following preferred terms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles, Injection site exfoliation, Injection site erosion, Injection site ulcer, Injection site necrosis. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA. Subjects having more than one event may appear in more than one System Organ Class or Preferred Term but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur.
Outcome measures
| Measure |
Part 1 - All Cohorts
n=10 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erythema: Severe
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Induration: Mild
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Induration: Moderate
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Induration: Severe
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Necrosis: Mild
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Necrosis: Moderate
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Necrosis: Severe
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Swelling: Mild
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Swelling: Moderate
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Swelling: Severe
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erosion: Mild
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erosion: Moderate
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erythema: Mild
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erythema: Moderate
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erosion: Severe
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Exfoliation: Mild
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Exfoliation: Moderate
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Exfoliation: Severe
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Ulcer: Mild
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Ulcer: Moderate
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Ulcer: Severe
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Vesicles: Mild
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Vesicles: Moderate
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Vesicles: Severe
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 15 weeksPopulation: Safety Population
Part 2: Percent of subjects with adverse events, treatment-related AEs
Outcome measures
| Measure |
Part 1 - All Cohorts
n=6 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 Participants
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=10 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=26 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=10 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=27 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 2: Percent of Subjects With Adverse Events
|
6 Participants
|
3 Participants
|
10 Participants
|
26 Participants
|
10 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Up to 15 weeksPopulation: Enrolled Subjects
Part 2: Percentage of subjects with study discontinuations due to adverse events.
Outcome measures
| Measure |
Part 1 - All Cohorts
n=6 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 Participants
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=10 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=26 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=10 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=27 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 2: Percentage of Subjects With Study Discontinuations Due to Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Treatment Days up to 2 weeksPopulation: Safety Population
Subjects with pre-determined TRAEs of SI such as hypotension (specific criteria); significant elevation of serum tryptase; Grade 2 or higher adverse event (with specific criteria)
Outcome measures
| Measure |
Part 1 - All Cohorts
n=6 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 Participants
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=10 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=26 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=10 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=27 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)
Not applicable
|
5 Participants
|
3 Participants
|
10 Participants
|
22 Participants
|
6 Participants
|
26 Participants
|
|
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)
Hypotension
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)
Blood Pressure Diastolic Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)
Blood Pressure Systolic Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)
Injection Site Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)
Injection Site Reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Percent of Subjects With Treatment Related Adverse Events of Special Interest (TRAEs SI)
Urticaria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 105 daysPopulation: Safety Population
Evaluation of the tissue condition at the treatment site for the presence and severity of each of the following cutaneous reactions; Erythema, Induration, Swelling, Blister Formation, Desquamation, Erosion, Ulceration, Necrosis by a scale of None; Mild; Moderate; Severe. Subjects having more than one event may appear in more than one SOC or PT but are counted at most once per each SOC and PT at the maximum severity. Cutaneous injection site reactions are types of reactions that can be expected to occur. The intended scale for cutaneous injection site reactions is mild, moderate, severe from CRA
Outcome measures
| Measure |
Part 1 - All Cohorts
n=6 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 Participants
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=10 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=26 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=10 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=27 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Vesicles · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erythema · Mild
|
5 Participants
|
2 Participants
|
4 Participants
|
13 Participants
|
4 Participants
|
3 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erythema · Moderate
|
1 Participants
|
1 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
19 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erythema · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erythema · Not applicable
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Induration · Mild
|
4 Participants
|
1 Participants
|
5 Participants
|
13 Participants
|
6 Participants
|
9 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Induration · Moderate
|
1 Participants
|
0 Participants
|
3 Participants
|
10 Participants
|
3 Participants
|
16 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Induration · Not applicable
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Necrosis · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Necrosis · Moderate
|
0 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Necrosis · Severe
|
4 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
13 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Necrosis · Not applicable
|
2 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Swelling · Mild
|
3 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
11 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Swelling · Moderate
|
0 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
13 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Swelling · Not applicable
|
3 Participants
|
1 Participants
|
1 Participants
|
11 Participants
|
2 Participants
|
3 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erosion · Mild
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erosion · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erosion · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Erosion · Not applicable
|
5 Participants
|
2 Participants
|
6 Participants
|
18 Participants
|
2 Participants
|
13 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Exfoliation · Mild
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
9 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Exfoliation · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Exfoliation · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Exfoliation · Not applicable
|
5 Participants
|
2 Participants
|
6 Participants
|
19 Participants
|
6 Participants
|
15 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Ulcer · Mild
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Ulcer · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Ulcer · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Ulcer · Not applicable
|
5 Participants
|
3 Participants
|
7 Participants
|
20 Participants
|
2 Participants
|
18 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Vesicles · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Vesicles · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Part 2: Percentage of Subjects With Cutaneous Reaction by Maximum Severity
Vesicles · Not applicable
|
6 Participants
|
3 Participants
|
7 Participants
|
24 Participants
|
10 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 84-91Population: Full Analysis Population. Participants with the Physician Global Assessment completed at the End of Treatment Visit. Report is based on Target Lesion 01 and Target Lesion 2 data in separate rows.
Clinical clearance of Target Lesion at excision as determined by visual assessment (no residual tumor seen on visual inspection). Clinical assessment using Physician Global Assessment (PGA). PGA scale: 100% Improvement, no visible tumor; 75% to less than 100% improvement, 50% to less than 75% improvement, 25% to less than 50% improvement, Up to 25% improvement, No change, Worse.
Outcome measures
| Measure |
Part 1 - All Cohorts
n=7 Target Lesions
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 Target Lesions
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=9 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=30 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=11 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=31 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · 100% Improvement, no visible tumor
|
5 Target Lesions
|
1 Target Lesions
|
6 Target Lesions
|
14 Target Lesions
|
5 Target Lesions
|
19 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · 75% to less than 100% improvement
|
0 Target Lesions
|
1 Target Lesions
|
3 Target Lesions
|
2 Target Lesions
|
2 Target Lesions
|
4 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · 50% to less than 75% improvement
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
4 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · 25% to less than 50% improvement
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
2 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · Up to 25% improvement
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
2 Target Lesions
|
0 Target Lesions
|
1 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · No change
|
1 Target Lesions
|
1 Target Lesions
|
0 Target Lesions
|
3 Target Lesions
|
0 Target Lesions
|
1 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · Worse
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · 100% Improvement, no visible tumor
|
1 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
4 Target Lesions
|
1 Target Lesions
|
5 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · 75% to less than 100% improvement
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · 50% to less than 75% improvement
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
1 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · 25% to less than 50% improvement
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · Up to 25% improvement
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · No change
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
1 Target Lesions
|
0 Target Lesions
|
1 Target Lesions
|
|
Part 2: Percentage of Subjects With Clinical Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · Worse
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
SECONDARY outcome
Timeframe: Day 84-91Population: Full Analysis Population. Participants with Target Lesion(s) excised and histology confirmed by central dermatopathologist. Report is based on Target Lesion 01 and Target Lesion 2 data presented in separate rows. NOTE: All participants had a Target Lesion 1, however, not all participants had a Target Lesion 2, therefore, the numbers are not the same.
Percentage of Subjects with histological clearance of treated lesion(s) at excision. Histologic clearance confirmed by central dermatopathologist. Percentage is calculated using the number of subjects with non-missing responses within lesion as the denominator. \*Scar indicates complete histologic clearance
Outcome measures
| Measure |
Part 1 - All Cohorts
n=7 Target Lesions
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 Target Lesions
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=9 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=29 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=11 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=31 Target Lesions
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · Focal Nodular
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · Micronodular
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · Nodular
|
0 Target Lesions
|
1 Target Lesions
|
2 Target Lesions
|
8 Target Lesions
|
1 Target Lesions
|
7 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · Superficial
|
1 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
2 Target Lesions
|
1 Target Lesions
|
1 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · Superficial Nodular
|
0 Target Lesions
|
1 Target Lesions
|
2 Target Lesions
|
2 Target Lesions
|
4 Target Lesions
|
3 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 1 · Scar (Complete histologic clearance)
|
5 Target Lesions
|
1 Target Lesions
|
5 Target Lesions
|
13 Target Lesions
|
3 Target Lesions
|
14 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · Focal Nodular
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · Micronodular
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · Nodular
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
1 Target Lesions
|
0 Target Lesions
|
2 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · Superficial
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
1 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · Superficial Nodular
|
1 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
1 Target Lesions
|
1 Target Lesions
|
|
Part 2: Percentage of Subjects With Histological Clearance of Treated Lesion(s) at Excision
Target Lesion 2 · Scar (Complete histologic clearance)
|
0 Target Lesions
|
0 Target Lesions
|
0 Target Lesions
|
2 Target Lesions
|
1 Target Lesions
|
3 Target Lesions
|
SECONDARY outcome
Timeframe: Day 84-91Population: Full Analysis Population
Estimate of remaining tumor volume (necrotic cells:tumor cells) at excision by central dermatopathologist Scale: 0 = None Remaining to 100 = All Remaining.
Outcome measures
| Measure |
Part 1 - All Cohorts
n=6 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 Participants
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=9 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=25 Participants
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=9 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=25 Participants
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 2: Mean Estimated Remaining Tumor Volume at Excision
Target Lesion 1
|
1.7 units on a scale
Standard Deviation 4.08
|
11.7 units on a scale
Standard Deviation 12.58
|
11.1 units on a scale
Standard Deviation 19.49
|
14.8 units on a scale
Standard Deviation 22.10
|
22.6 units on a scale
Standard Deviation 25.45
|
14.3 units on a scale
Standard Deviation 21.00
|
|
Part 2: Mean Estimated Remaining Tumor Volume at Excision
Target Lesion 2
|
5.0 units on a scale
|
—
|
—
|
6.3 units on a scale
Standard Deviation 9.46
|
7.5 units on a scale
Standard Deviation 10.61
|
13.3 units on a scale
Standard Deviation 27.87
|
SECONDARY outcome
Timeframe: Day 1-2Population: PK Population - Part 2, Cohorts 4 Expansion and 5 Expansion subjects that consented to participate. Includes subjects in Safety Population with quantifiable PK concentration data.
Pharmacokinetics (PK) of an 8 mg dose of VP-315 administered with the optimal dosing regimen
Outcome measures
| Measure |
Part 1 - All Cohorts
n=9 Participants
Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=14 Participants
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|
|
Part 2 (Cohorts 4 and 5 Expansion Groups): Plasma Concentrations of VP-315
|
32.1 h*ng/mL
Standard Deviation 2.95
|
29.4 h*ng/mL
Standard Deviation 13.78
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1 - All Cohorts
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2 - Cohort 4 Expansion Optimal Dosing
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Part 2 - Cohort 5 Expansion: Optimal
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1 - All Cohorts
n=10 participants at risk
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan. Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose
n=6 participants at risk
VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 participants at risk
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=10 participants at risk
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=26 participants at risk
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=10 participants at risk
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=27 participants at risk
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Infections and infestations
Influenza
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
Other adverse events
| Measure |
Part 1 - All Cohorts
n=10 participants at risk
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan. Cohorts 1-7: Starting total daily dose of VP-315 was 2-8 mg. Subjects will receive ascending once daily doses increasing in 1 mg increments for up to 3 days in a 7-day treatment week (e.g., 2 mg on Day 1, 3 mg on Day 2) until the first lesion is necrosed or a DLT occurs. Subjects may be treated for a maximum of 2 weeks and a maximum total daily dose of 8 mg.
Part 1: VP-315 3 Day Dosing/Week: 2-8 mg of VP-315 administered via intratumor injection into a single target lesion on W1D1. Each 500-μL dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. In all parts of the study, the targeted total volume of delivery is 500 μL daily.
|
Part 2 - Cohort 1: Optimal Dosing Regimen of 3 Daily Doses of VP-315, 4 mg Loading Dose
n=6 participants at risk
VP-315 once-daily dosing of 8 mg with a loading dose of half the target dose of 8 mg (i.e. 4 mg) only on W1D1; all remaining doses will be the full target dose without a loading dose. Subjects will be treated until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - Loading Dose: 4mg (halt the target dose) loading dose on W1D1 administered via intratumor injection into a single target lesion, followed by total daily doses at the full target dose of 8 mg on the remaining days of treatment.
|
Part 2 - Cohort 2: Optimal Dosing Regimen of 3 Daily Doses of VP-315 no Loading Dose
n=3 participants at risk
VP-315 once-daily dosing of 8 mg on all treatment days (i.e., NO LOADING dose on W1D1) for up to 3 consecutive daily doses/week until the lesion is necrosed, for a maximum of 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
Part 2: VP-315 3 Day Dosing/Week - No Loading Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4: Optimal Dosing Regimen of 2 Daily Doses of VP-315 8 mg (Split Dose)
n=10 participants at risk
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 4 Expansion Optimal Dosing
n=26 participants at risk
VP-315 once-daily dosing of 8 mg, administered on 2 consecutive days in one week (W1D1, W1D2). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second Target Lesion may begin on D1 of the next week (W2D1, W2D2). Each individual target lesion is treated for the assigned 2 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 4 total doses.
Part 2: VP-315 2 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 2 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5: Optimal Dosing Regimen of 3 Daily Doses of VP-315 8 mg (Split Dose)
n=10 participants at risk
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
Part 2 - Cohort 5 Expansion: Optimal
n=27 participants at risk
VP-315 once-daily dosing of 8 mg, administered on 3 consecutive days in one week (W1D1, W1D2, W1D3). The planned dosing regimen will be a split dose of VP-315 for all treatments. The 500μL (8 mg) dose will be divided into 2 injections given at least 15 minutes and no more than 30 minutes apart, with 30% (150 μL) administered in the first injection and the remaining 70% (350 μL) with the second injection. Treatment for a second target lesion may begin on D1 of the next week (W2D1, W2D2, W2D3). Each individual target lesion is treated for the assigned 3 days only (regardless of necrosis status). Up to 2 target lesions may be treated - up to 6 total doses.
Part 2: VP-315 3 Day Dosing/Week - Split Dose: 8 mg of VP-315 administered daily via intratumor injection into a single target lesion up to 3 consecutive daily doses/week for up to 2 weeks (W1D1, W1D2, W1D3 and W2D1, W2D2, W2D3 - up to 6 total doses).
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Postoperative wound infection
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Post procedural erythema
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
3.8%
1/26 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung carcinoma
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Erythema; Injection site erythema
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site erythema
|
70.0%
7/10 • Number of events 7 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
100.0%
6/6 • Number of events 6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
100.0%
3/3 • Number of events 3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
100.0%
10/10 • Number of events 10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
92.3%
24/26 • Number of events 24 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
100.0%
10/10 • Number of events 10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
96.3%
26/27 • Number of events 26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site induration
|
80.0%
8/10 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
83.3%
5/6 • Number of events 5 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
33.3%
1/3 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
80.0%
8/10 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
88.5%
23/26 • Number of events 23 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
100.0%
10/10 • Number of events 10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
96.3%
26/27 • Number of events 26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site necrosis
|
70.0%
7/10 • Number of events 7 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
66.7%
4/6 • Number of events 4 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
66.7%
2/3 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
80.0%
8/10 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
73.1%
19/26 • Number of events 19 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
90.0%
9/10 • Number of events 9 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
92.6%
25/27 • Number of events 25 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site swelling
|
70.0%
7/10 • Number of events 7 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
50.0%
3/6 • Number of events 3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
66.7%
2/3 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
80.0%
8/10 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
57.7%
15/26 • Number of events 15 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
80.0%
8/10 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
88.9%
24/27 • Number of events 24 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site erosion
|
60.0%
6/10 • Number of events 6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
16.7%
1/6 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
33.3%
1/3 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
40.0%
4/10 • Number of events 4 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
30.8%
8/26 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
80.0%
8/10 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
51.9%
14/27 • Number of events 14 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site exfoliation
|
70.0%
7/10 • Number of events 7 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
16.7%
1/6 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
33.3%
1/3 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
40.0%
4/10 • Number of events 4 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
26.9%
7/26 • Number of events 7 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
40.0%
4/10 • Number of events 4 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
44.4%
12/27 • Number of events 12 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site ulcer
|
50.0%
5/10 • Number of events 5 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
16.7%
1/6 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
30.0%
3/10 • Number of events 3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
23.1%
6/26 • Number of events 6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
80.0%
8/10 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
33.3%
9/27 • Number of events 9 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site pain
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
16.7%
1/6 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
66.7%
2/3 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
40.0%
4/10 • Number of events 4 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
23.1%
6/26 • Number of events 6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
29.6%
8/27 • Number of events 8 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site vesicles
|
30.0%
3/10 • Number of events 3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
30.0%
3/10 • Number of events 3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
7.7%
2/26 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
25.9%
7/27 • Number of events 7 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Fatigue
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
20.0%
2/10 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Injection site oedema
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
General disorders
Peripheral swelling
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Vascular disorders
Hypertension
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
20.0%
2/10 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
3.7%
1/27 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
20.0%
2/10 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
3.7%
1/27 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
2/10 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
16.7%
1/6 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
11.5%
3/26 • Number of events 3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Hypertrophic Scar
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
7.7%
2/26 • Number of events 2 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Investigations
Body temperature increased
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Investigations
Blood pressure decreased
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
3.8%
1/26 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/6 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/3 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
10.0%
1/10 • Number of events 1 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/26 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/10 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
0.00%
0/27 • 4-5 months After the informed consent is signed through the end of study follow-up visit. (up to 42 days Screening; treatment in 1-week intervals; surgical excision of all target and nontarget lesions 4 to 6 weeks (Part 1) and 12 to 14 weeks after W1D1 injection; follow-up (F/U) visit at 1- or 2-weeks post excision).
Due to the small number of subjects in each Cohort for Part 1, adverse events for Part 1 are reported with all subjects (10) combined per the Statistical Analysis Plan.
|
Additional Information
Susan Cutler, VP Medical Affairs
Verrica Pharmaceuticals
Phone: 484-773-089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution is restricted from disclosing all data or results which are the sole property of the sponsor and considered confidential information. The Institution may not present data or results without prior Sponsor review and written consent
- Publication restrictions are in place
Restriction type: OTHER