Trial Outcomes & Findings for NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC (NCT NCT04880863)
NCT ID: NCT04880863
Last Updated: 2025-03-03
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and iRECIST for target lesions and assessed by CT scans or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
38 participants
Primary outcome timeframe
From the first treatment to first CR or PR (estimated about 24 months)
Results posted on
2025-03-03
Participant Flow
Participant milestones
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Patient decision
|
2
|
|
Overall Study
Confirmed Disease Progression
|
15
|
|
Overall Study
Death
|
3
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Unconfirmed Disease Progression
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Study discontinuation by the sponsor
|
4
|
|
Overall Study
Progression disease identified by lumbar puncture
|
1
|
|
Overall Study
Not received study drug NAP
|
2
|
Baseline Characteristics
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC
Baseline characteristics by cohort
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=38 Participants
Subjects received obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP was administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel were 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg was administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP was given as monotherapy and not earlier than C7, cycles were of 28 days of duration.
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|---|---|
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Age, Continuous
|
66 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the first treatment to first CR or PR (estimated about 24 months)Population: Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and iRECIST for target lesions and assessed by CT scans or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=32 Participants
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
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Objective Response Rate (ORR)
|
15.6 percentage of responders
Interval 5.3 to 32.8
|
SECONDARY outcome
Timeframe: From the first administration of treatment till study completion (estimated about 24 months).Population: Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues.
The proportion of subjects who achieve a best response of CR, PR or SD per Response Evaluation in Solid Tumors (iRECIST).
Outcome measures
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=32 Participants
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
|
Disease Control Rate (DCR)
|
71.9 percentage of patients with SD, PR, CR
Interval 53.3 to 86.3
|
SECONDARY outcome
Timeframe: estimated about 24 months.Population: Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues.
Duration from first documentation of CR or PR (whichever occurs first) after the first administration of obinutuzumab pretreatment until death or progressive disease (PD)
Outcome measures
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=32 Participants
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
|
Duration of Response (DOR)
|
12.2 months
Interval 1.6 to 17.7
|
SECONDARY outcome
Timeframe: From the first administration of treatment to the date of first documentation of disease progression, or death due to any cause, whichever occurs first (estimated about 24 months).Population: Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues.
PFS per Response Evaluation in Solid Tumors (iRECIST)
Outcome measures
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=32 Participants
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
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Progression-free Survival (PFS)
|
8.8 months
Interval 6.1 to 15.2
|
SECONDARY outcome
Timeframe: estimated about 24 months.Population: Efficacy Evaluable Population: patients completing at least one treatment cycle and having had an evaluable pre-treatment and one post-treatment tumor assessment (according to the iRECIST - criteria) in the absence of eligibility and compliance issues.
The time from first day of study drug treatment to death for any cause
Outcome measures
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=32 Participants
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
|
Overall Survival (OS)
|
8.8 months
Interval 6.4 to 11.7
|
SECONDARY outcome
Timeframe: From the first administration of obinutuzumab pretreatment till study completion (estimated about 24 months).Population: Safety Subjects Population
Number of subjects with treatment emergent adverse events as assessed by CTCAE v5.0
Outcome measures
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=38 Participants
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
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Treatment-Emergent Adverse Events (TEAEs)
TEAE Grade 1 or 2
|
37 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAEs Grade ≥3
|
34 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to Docetaxel Grade 1 or 2
|
28 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to Obinutuzumab Grade ≥ 3
|
6 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to NAP Grade 1 or 2
|
33 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to NAP Grade ≥ 3
|
22 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to NAP when given as a single agent Grade 1 or 2
|
4 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to NAP when given as a single agent Grade ≥ 3
|
3 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to Docetaxel Grade ≥ 3
|
27 participants
|
|
Treatment-Emergent Adverse Events (TEAEs)
TEAE Related to Obinutuzumab Grade 1 or 2
|
18 participants
|
Adverse Events
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
Serious events: 16 serious events
Other events: 38 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=38 participants at risk
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
General disorders
Pain
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Infections and infestations
Pneumonia
|
10.5%
4/38 • Number of events 4 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Investigations
Neutrophil count decreased
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Metabolism and nutrition disorders
Fluid overload
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Vascular disorders
Hypotension
|
5.3%
2/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Cardiac disorders
Cardiac arrest
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Infections and infestations
COVID-19
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Psychiatric disorders
Mental status changes
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.6%
1/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
1/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Infections and infestations
Sepsis
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Vascular disorders
Superior vena cava syndrome
|
2.6%
1/38 • Number of events 1 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
Other adverse events
| Measure |
NAP in Combination With Docetaxel Following Obinutuzumab Pretreatment
n=38 participants at risk
Subjects will receive obinutuzumab, 1,000 mg, administered by IV infusion on Days -13 and -12 of the first treatment cycle in order to reduce the titer of anti-drug antibodies to NAP. NAP will be administered in a daily dose of 10 μg/kg by IV bolus on Days 1 - 4 of treatment cycles 1-6, followed by docetaxel, 75 mg/m2 on Day 5. Treatment cycles with the combination NAP/docetaxel will be 21 days in duration. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1 and docetaxel on Day 2, in 21 days treatment cycles. Once NAP is given as monotherapy and not earlier than C7, cycles will be of 28 days of duration.
NAP (Naptumomab estafenatox): Naptumomab estafenatox (NAP; ABR-217620) is a recombinant fusion protein consisting of a chimeric staphylococcal enterotoxin A/E (SEA/SEE) superantigen with several additional substitutions that is linked to a Fab moiety recognizing a tumor-associated glycoprotein, 5T4. NAP will be administered in a dose of 10 μg/kg/day by IV bolus on Days 1 - 4 of treatment cycles 1-6. Starting cycle 7, NAP at a higher dose of 15 μg/kg will be administered on Day 1.
Docetaxel: Docetaxel is administered in combination with the study drug, NAP, on Day 5 of the treatment cycles 1-6. Starting cycle 7, Docetaxel will be administered in combination with the study drug, NAP, on Day 2.
Obinutuzumab: Obinutuzumab is administered as pre-medication on Day -13 and -12 of the first treatment cycle.
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Blood and lymphatic system disorders
Anaemia
|
28.9%
11/38 • Number of events 14 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Cardiac disorders
Tachycardia
|
21.1%
8/38 • Number of events 11 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Cardiac disorders
Atrial fibrillation
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Endocrine disorders
Hypothyroidism
|
7.9%
3/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Nausea
|
42.1%
16/38 • Number of events 25 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Diarrhoea
|
31.6%
12/38 • Number of events 16 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Vomiting
|
28.9%
11/38 • Number of events 17 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Constipation
|
28.9%
11/38 • Number of events 14 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
21.1%
8/38 • Number of events 13 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Abdominal pain upper
|
7.9%
3/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
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Gastrointestinal disorders
Dysphagia
|
7.9%
3/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Abdominal discomfort
|
5.3%
2/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Abdominal distension
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Dyspepsia
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Gastrointestinal disorders
Oral pain
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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General disorders
Fatigue
|
63.2%
24/38 • Number of events 43 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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General disorders
Chills
|
57.9%
22/38 • Number of events 37 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
General disorders
Pyrexia
|
31.6%
12/38 • Number of events 17 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
General disorders
Pain
|
26.3%
10/38 • Number of events 13 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
General disorders
Oedema peripheral
|
21.1%
8/38 • Number of events 11 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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General disorders
Asthenia
|
10.5%
4/38 • Number of events 6 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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General disorders
Chest pain
|
10.5%
4/38 • Number of events 4 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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General disorders
Mucosal inflammation
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Infections and infestations
Pneumonia
|
15.8%
6/38 • Number of events 8 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Infections and infestations
Urinary tract infection
|
13.2%
5/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Infections and infestations
COVID-19
|
10.5%
4/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Infections and infestations
Upper respiratory tract infection
|
5.3%
2/38 • Number of events 4 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Infections and infestations
Sinusitis
|
5.3%
2/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Infections and infestations
Bronchitis
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Infections and infestations
Diverticulitis
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Infections and infestations
Infection
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Injury, poisoning and procedural complications
Fall
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Injury, poisoning and procedural complications
Wound complication
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
Neutrophil count decreased
|
55.3%
21/38 • Number of events 32 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
Investigations
Weight decreased
|
18.4%
7/38 • Number of events 8 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
White blood cell count decreased
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13.2%
5/38 • Number of events 7 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
Aspartate aminotransferase increased
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10.5%
4/38 • Number of events 6 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
Blood creatinine increased
|
10.5%
4/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
Gamma-glutamyltransferase increased
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10.5%
4/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
Blood alkaline phosphatase increased
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7.9%
3/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
Alanine aminotransferase increased
|
5.3%
2/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
Lymphocyte count decreased
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5.3%
2/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Investigations
Platelet count decreased
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5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Metabolism and nutrition disorders
Hypomagnesaemia
|
28.9%
11/38 • Number of events 17 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Metabolism and nutrition disorders
Decreased appetite
|
23.7%
9/38 • Number of events 11 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Metabolism and nutrition disorders
Dehydration
|
18.4%
7/38 • Number of events 9 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Metabolism and nutrition disorders
Hypokalaemia
|
18.4%
7/38 • Number of events 9 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
Metabolism and nutrition disorders
Hyponatraemia
|
13.2%
5/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.9%
3/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
2/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Metabolism and nutrition disorders
Hyperuricaemia
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Musculoskeletal and connective tissue disorders
Arthralgia
|
26.3%
10/38 • Number of events 11 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Musculoskeletal and connective tissue disorders
Back pain
|
18.4%
7/38 • Number of events 8 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.2%
5/38 • Number of events 6 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Musculoskeletal and connective tissue disorders
Bone pain
|
13.2%
5/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
13.2%
5/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.5%
4/38 • Number of events 4 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.9%
3/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Nervous system disorders
Headache
|
23.7%
9/38 • Number of events 12 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Nervous system disorders
Dizziness
|
18.4%
7/38 • Number of events 7 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Nervous system disorders
Peripheral sensory neuropathy
|
13.2%
5/38 • Number of events 6 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Nervous system disorders
Dysgeusia
|
5.3%
2/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Nervous system disorders
Dysaesthesia
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Psychiatric disorders
Insomnia
|
13.2%
5/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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|
Psychiatric disorders
Anxiety
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
39.5%
15/38 • Number of events 21 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
6/38 • Number of events 10 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.8%
6/38 • Number of events 7 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
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Skin and subcutaneous tissue disorders
Alopecia
|
23.7%
9/38 • Number of events 9 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Skin and subcutaneous tissue disorders
Rash
|
10.5%
4/38 • Number of events 4 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Skin and subcutaneous tissue disorders
Pruritus
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7.9%
3/38 • Number of events 5 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Skin and subcutaneous tissue disorders
Nail disorder
|
7.9%
3/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
2/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Vascular disorders
Hypotension
|
34.2%
13/38 • Number of events 19 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Vascular disorders
Hypertension
|
15.8%
6/38 • Number of events 11 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Vascular disorders
Flushing
|
5.3%
2/38 • Number of events 3 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
|
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Vascular disorders
Hot flush
|
5.3%
2/38 • Number of events 2 • Treatment Emergent AEs were collected from first study drug administration till 30 days post last subject last visit, i.e. through study completion, an average of 2 years.
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Additional Information
Dr. Ilana Lorber, VP of Clinical Operations
NeoTX Therapeutics Ltd.
Phone: +972-3-912-5853
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study Sites or Principal Investigators shall not publish the Results or the outcomes of their individual participation in the Study, until after the completion of the Study at all participating sites and the review, analysis, and write-up of the Study by the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER