Trial Outcomes & Findings for HCW9218 in Select Advanced Solid Tumors (NCT NCT05322408)
NCT ID: NCT05322408
Last Updated: 2025-11-05
Results Overview
Given that little to no toxicity is expected, the MTD will be determined using an adaptation of the continual reassessment method (CRM) (O'Quigley, 1996) starting with 1 patient cohorts.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
through study completion, an average of 12 months
Results posted on
2025-11-05
Participant Flow
Participant milestones
| Measure |
HCW9218 Dose Level -1
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks.
Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 1
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
3
|
3
|
9
|
|
Overall Study
COMPLETED
|
0
|
3
|
3
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HCW9218 in Select Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
HCW9218 Dose Level 1
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=9 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
6 Participants
n=3 Participants
|
14 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
6 Participants
n=3 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
3 Participants
n=3 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
9 Participants
n=3 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=15 Participants
|
3 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
7 Participants
n=3 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=15 Participants
|
3 participants
n=161 Participants
|
3 participants
n=100 Participants
|
9 participants
n=3 Participants
|
18 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 12 monthsGiven that little to no toxicity is expected, the MTD will be determined using an adaptation of the continual reassessment method (CRM) (O'Quigley, 1996) starting with 1 patient cohorts.
Outcome measures
| Measure |
Administer HCW9218
n=18 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
The Primary Objective of the Dose Finding Component is to Determine the Maximum Tolerated Dose (MTD) of HCW9218
|
1.2 mg/kg
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months after 1st doseResponse rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
Outcome measures
| Measure |
Administer HCW9218
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=9 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
Estimate Response Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 months after 1st doseResponse rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
Outcome measures
| Measure |
Administer HCW9218
n=1 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=2 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=2 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=6 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
Estimate Response Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months after 1st dosePopulation: Unable to analyze participants in dose level 1 due to all cause mortality.
Response rate will be estimated by a simple proportion with 95% confidence limits if sufficient numbers exist
Outcome measures
| Measure |
Administer HCW9218
n=1 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=1 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=1 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=5 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
Estimate Response Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after 1st doseEstimated with Kaplan-Meier curves
Outcome measures
| Measure |
Administer HCW9218
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=9 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
Estimate Progression of Overall Survival (OS)
|
67 Percentage of participants
Interval 5.0 to 95.0
|
67 Percentage of participants
Interval 5.0 to 95.0
|
67 Percentage of participants
Interval 5.0 to 95.0
|
78 Percentage of participants
Interval 36.0 to 94.0
|
SECONDARY outcome
Timeframe: 6 months after 1st doseEstimated with Kaplan-Meier curves
Outcome measures
| Measure |
Administer HCW9218
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=9 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
Estimate Progression Free Survival (PFS)
|
33 Percentage of participants
Interval 1.0 to 77.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
11 Percentage of participants
Interval 1.0 to 39.0
|
SECONDARY outcome
Timeframe: 1 year after 1st doseEstimated with Kaplan-Meier curves
Outcome measures
| Measure |
Administer HCW9218
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=9 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
Estimate Progression Free Survival (PFS)
|
33 Percentage of participants
Interval 1.0 to 77.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
11 Percentage of participants
Interval 1.0 to 39.0
|
SECONDARY outcome
Timeframe: 1 year after 1st doseEstimated with Kaplan-Meier curves
Outcome measures
| Measure |
Administer HCW9218
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=3 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=9 Participants
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
Estimate Progression of Overall Survival (OS)
|
33 Percentage of participants
Interval 1.0 to 77.0
|
33 Percentage of participants
Interval 1.0 to 77.0
|
33 Percentage of participants
Interval 1.0 to 77.0
|
67 Percentage of participants
Interval 28.0 to 88.0
|
Adverse Events
HCW9218 Dose Level 1
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
HCW9218 Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
HCW9218 Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
HCW9218 Dose Level 4
Serious events: 4 serious events
Other events: 9 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
HCW9218 Dose Level 1
n=3 participants at risk
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=3 participants at risk
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=3 participants at risk
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=9 participants at risk
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
66.7%
2/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
General disorders
Ascites
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Infections and infestations
Other, specify - C.Diff Infection
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary Tract Obstruction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colonic obstruction - Partial bowel obstruction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Cardiac disorders
Thromboembolic event
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
HCW9218 Dose Level 1
n=3 participants at risk
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 2
n=3 participants at risk
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 3
n=3 participants at risk
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
HCW9218 Dose Level 4
n=9 participants at risk
Administer HCW9218 as monotherapy at assigned dose by SC injection once every 3 weeks. Dose Level
-1 - 0.1 mg/kg
1. \- (start) 0.25 mg/kg
2. \- 0.5 mg/kg
3. \- 0.8 mg/kg
4. \- 1.2 mg/kg
HCW9218: HCW9218 at the assigned dose level is administered as a subcutaneous injection once every 3 weeks for a minimum of 2 treatment cycles unless medically contraindicated.
|
|---|---|---|---|---|
|
General disorders
Disease progression
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
|
General disorders
Chills
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
General disorders
Edema limbs
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Pain
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 6 • 1 year
|
100.0%
3/3 • Number of events 6 • 1 year
|
100.0%
3/3 • Number of events 7 • 1 year
|
88.9%
8/9 • Number of events 19 • 1 year
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
100.0%
3/3 • Number of events 5 • 1 year
|
55.6%
5/9 • Number of events 8 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
66.7%
2/3 • Number of events 5 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
55.6%
5/9 • Number of events 16 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
6/9 • Number of events 10 • 1 year
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
55.6%
5/9 • Number of events 11 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
33.3%
3/9 • Number of events 7 • 1 year
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
55.6%
5/9 • Number of events 10 • 1 year
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
55.6%
5/9 • Number of events 6 • 1 year
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
|
Investigations
Weight loss
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
55.6%
5/9 • Number of events 6 • 1 year
|
|
Investigations
INR increased
|
66.7%
2/3 • Number of events 3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
3/9 • Number of events 4 • 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
3/9 • Number of events 7 • 1 year
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • Number of events 6 • 1 year
|
|
Investigations
Weight gain
|
33.3%
1/3 • Number of events 4 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Investigations
Cardiac troponin T increased
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Investigations
Thyroid stimulating hormone increased
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
3/3 • Number of events 3 • 1 year
|
66.7%
2/3 • Number of events 3 • 1 year
|
33.3%
1/3 • Number of events 3 • 1 year
|
55.6%
5/9 • Number of events 14 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Number of events 7 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
66.7%
6/9 • Number of events 15 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 6 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
66.7%
2/3 • Number of events 6 • 1 year
|
66.7%
6/9 • Number of events 13 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 1 year
|
100.0%
3/3 • Number of events 4 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
44.4%
4/9 • Number of events 4 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
44.4%
4/9 • Number of events 10 • 1 year
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
66.7%
2/3 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
22.2%
2/9 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • Number of events 6 • 1 year
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 3 • 1 year
|
100.0%
3/3 • Number of events 5 • 1 year
|
66.7%
2/3 • Number of events 6 • 1 year
|
55.6%
5/9 • Number of events 11 • 1 year
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
44.4%
4/9 • Number of events 5 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
66.7%
2/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • Number of events 3 • 1 year
|
22.2%
2/9 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
44.4%
4/9 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
44.4%
4/9 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
44.4%
4/9 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
55.6%
5/9 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
0.00%
0/9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
33.3%
3/9 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
3/9 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 2 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • Number of events 3 • 1 year
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Nervous system disorders
Spinal cord compression
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
44.4%
4/9 • Number of events 8 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Renal and urinary disorders
Glucosuria
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Renal and urinary disorders
Urine discoloration
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
66.7%
2/3 • Number of events 3 • 1 year
|
66.7%
2/3 • Number of events 3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
3/9 • Number of events 9 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Cardiac disorders
Heart failure
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
33.3%
1/3 • Number of events 1 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
44.4%
4/9 • Number of events 5 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
22.2%
2/9 • Number of events 6 • 1 year
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
66.7%
2/3 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
33.3%
1/3 • Number of events 4 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
|
Endocrine disorders
Hyperparathyroidism
|
33.3%
1/3 • Number of events 1 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/3 • 1 year
|
0.00%
0/3 • 1 year
|
55.6%
5/9 • Number of events 8 • 1 year
|
|
General disorders
Injection site reaction
|
100.0%
3/3 • Number of events 11 • 1 year
|
100.0%
3/3 • Number of events 15 • 1 year
|
100.0%
3/3 • Number of events 17 • 1 year
|
100.0%
9/9 • Number of events 44 • 1 year
|
|
General disorders
Flu like symptoms
|
33.3%
1/3 • Number of events 1 • 1 year
|
100.0%
3/3 • Number of events 7 • 1 year
|
100.0%
3/3 • Number of events 14 • 1 year
|
88.9%
8/9 • Number of events 22 • 1 year
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 2 • 1 year
|
33.3%
1/3 • Number of events 1 • 1 year
|
66.7%
2/3 • Number of events 2 • 1 year
|
88.9%
8/9 • Number of events 13 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place