NCT03504397 · OUTCOME
Number of Participants With Anti-drug Antibodies (ADA)
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. · Source last updated 2026-05-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow up
What was measured
Immunogenicity will be measured by the number of participants that are ADA positive.
Analysis population: Participants who were randomized to zolbetuximab + mFOLFOX6 Arm with at least One Valid Result for ADA.
Groups in this outcome
mFOLFOX6 + Zolbetuximab
Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 283 |
|---|
Reported measurements
C1D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 265 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
C1D22
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 182 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
C3D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 189 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
C5D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 139 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
C7D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 101 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
C9D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 59 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
30 day follow up
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 85 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
90 day follow up
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 76 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- C1D1
- title
- C1D22
- title
- C3D1
- title
- C5D1
- title
- C7D1
- title
- C9D1
- title
- 30 day follow up
- title
- 90 day follow up
- description
- Immunogenicity will be measured by the number of participants that are ADA positive.
- groups
- description
- Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
- id
- OG000
- title
- mFOLFOX6 + Zolbetuximab
- param Type
- NUMBER
- population Description
- Participants who were randomized to zolbetuximab + mFOLFOX6 Arm with at least One Valid Result for ADA.
- reporting Status
- POSTED
- time Frame
- Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow up
- title
- Number of Participants With Anti-drug Antibodies (ADA)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice