Trial Outcomes & Findings for A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (NCT NCT03343301)

Last Updated: 2024-02-28

Results Overview

A treatment-related adverse event (TRAE) is defined as an adverse event (AE) with an onset date on or after the date of first dose of study treatment, or an event present before treatment that worsened after treatment, and with an onset date prior to 28 days after the last date of dose, for which the investigator assessed as related to investigational product The investigator classified the severity of each AE using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

From first dose of study drug up to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in the bemarituzumab 6 mg/kg group and 19.4 (4.0, 35.4) weeks in the bemarituzumab 15 mg/kg group.

Results posted on

2024-02-28

Participant Flow

Study FPA144-004 was a Phase 1/2 study. Phase 1 was a safety run-in to determine the recommended dose of bemarituzumab to be administered in combination with a fixed dose of modified FOLFOX 6 (mFOLFOX6) chemotherapy regimen in the phase 2 part of the study. Phase 1 study results are reported herein; Phase 2 study details and results are reported separately (NCT03694522).

In Phase 1, dose cohorts were planned to begin at a bemarituzumab dose level of 6 mg/kg per dose, with enrollment into subsequent dose cohorts depending on safety and tolerability.

Participant milestones

Participant milestones
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 Participants received 6 mg/kg bemarituzumab administered every 2 weeks (Q2W) and modified FOLFOX6 (mFOLFOX6) chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Overall Study STARTED	3	9
Overall Study Received Any Study Treatment	3	9
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 Participants received 6 mg/kg bemarituzumab administered every 2 weeks (Q2W) and modified FOLFOX6 (mFOLFOX6) chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Overall Study Withdrawal by Subject	1	1
Overall Study Death	0	2
Overall Study Other	0	6
Overall Study Missing	2	0

Baseline Characteristics

A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=9 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.	Total n=12 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 21.46 • n=99 Participants	62.3 years STANDARD_DEVIATION 16.45 • n=107 Participants	62.9 years STANDARD_DEVIATION 16.78 • n=206 Participants
Age, Customized < 65 years	1 Participants n=99 Participants	5 Participants n=107 Participants	6 Participants n=206 Participants
Age, Customized >=65 years	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	9 Participants n=107 Participants	10 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants	7 Participants n=107 Participants	8 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized White	2 Participants n=99 Participants	7 Participants n=107 Participants	9 Participants n=206 Participants
Race/Ethnicity, Customized Other	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Fully active)	0 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Restricted activity but ambulatory)	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Anti-Cancer Treatment Prior to Enrollment Yes	2 Participants n=99 Participants	7 Participants n=107 Participants	9 Participants n=206 Participants
Anti-Cancer Treatment Prior to Enrollment No	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in the bemarituzumab 6 mg/kg group and 19.4 (4.0, 35.4) weeks in the bemarituzumab 15 mg/kg group.

Population: All participants who received any portion of at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=9 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Number of Participants With Treatment-related Adverse Events ≥ Grade 2	1 Participants	4 Participants

PRIMARY outcome

Timeframe: 28 days

Population: DLT-evaluable population includes all participants enrolled in Phase 1 of the study who received at least 2 doses of bemarituzumab (except for Cohort 2 \[must have received 3 doses of bemarituzumab\]) and mFOLFOX6 and completed Cycles 1 and 2 of treatment, or who experienced a DLT in Cycle 1 or Cycle 2.

DLTs were defined as any of the following events considered by the investigator to be related to study drug: * Absolute neutrophil count (ANC) \< 0.5 × 10⁹/L \> 5 days duration or febrile neutropenia. * Platelets \< 25 × 10⁹/L or \< 50 × 10⁹/L with bleeding requiring medical intervention or for \> 3 days. * Grade 4 anemia. * Any Grade 2-3 ophthalmologic AE not resolving within 7 days. * Any Grade 4 ophthalmologic AE. * Any Grade 4 laboratory value. * Any Grade 3 laboratory values that are not of clinical significance according to investigator and Sponsor agreement if they do not resolve within 72 hours. * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥ 3× upper limit of normal (ULN) and concurrent total bilirubin ≥ 2× ULN not related to liver involvement with cancer. * Any non-hematological AE ≥ Grade 3 (except nausea, vomiting, and diarrhea). * Grade 3 nausea, vomiting or diarrhea not resolving with supportive care in 72 hours. * Grade 4 nausea, vomiting or diarrhea.

Outcome measures

Outcome measures
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=8 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose of study drug up to 28 days after last dose; Actual median (min, max) duration of the treatment emergent period was 19.3 (12.3, 22.3) weeks in the bemarituzumab 6 mg/kg group and 19.4 (4.0, 35.4) weeks in the bemarituzumab 15 mg/kg group.

Population: All participants who received any portion of at least 1 dose of study treatment.

Treatment-emergent adverse events are defined as adverse events (AEs) that started or worsened between the start of study drug and 28 days after permanent discontinuation of study drug. A serious AE is defined as any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability or incapacity; * Was a congenital anomaly or birth defect. The investigator assessed the causality/relationship between the study treatment and each AE, and assessed the severity of each AE according to the guidelines provided in NCI-CTCAE, version 5.0 on a scale from mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death due to the AE (Grade 5). Ocular events associated with symptomatic corneal involvement and symptomatic and asymptomatic retinal involvement were events of special interest in this study.

Outcome measures

Outcome measures
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=9 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Number of Participants With Treatment-emergent Adverse Events TEAE with Grade ≥ 3	1 Participants	6 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE related to bemarituzumab	2 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE with Grade ≥ 3 related to any study drug	1 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE of special interest: corneal/retina	0 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE of special interest: corneal/retina related to bemarituzumab	0 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE of special interest: corneal/retina leading to discontinuation of bemarituzumab	0 Participants	2 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE leading to discontinuation of bemarituzumab	0 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE leading to discontinuation of any agent of mFOLFOX6	0 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events Any treatment-emergent adverse event (TEAE)	3 Participants	9 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE related to any study drug	3 Participants	9 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE related to any agent of mFOLFOX6	3 Participants	9 Participants
Number of Participants With Treatment-emergent Adverse Events Serious adverse event (SAE)	0 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events SAE related to any study drug	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events SAE related to bemarituzumab	0 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events SAE related to any agent of mFOLFOX6	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE leading to dose reduction of bemarituzumab	1 Participants	0 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE leading to dose reduction of any agent of mFOLFOX6	1 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events TEAE leading to death (Grade 5)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours end of infusion; Cycle 2 day 1 at predose, 0.25 and 48 hours after end of infusion.

Population: Participants who received bemarituzumab with available Cmax data

Outcome measures

Outcome measures
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=8 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Maximum Observed Serum Concentration (Cmax) of Bemarituzumab Cycle 1	119 µg/mL Standard Deviation 8.52	329 µg/mL Standard Deviation 60.3
Maximum Observed Serum Concentration (Cmax) of Bemarituzumab Cycle 2	123 µg/mL Standard Deviation 13.8	377 µg/mL Standard Deviation 82.8

SECONDARY outcome

Timeframe: Cycle 1 day 14 predose for cohort 1 and day 8 predose for cohort 2; Cycle 2 day 14 predose

Population: Participants who received bemarituzumab with available Ctrough data

Outcome measures

Outcome measures
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=8 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Observed Serum Concentration of Bemarituzumab at the End of the Dose Interval (Ctrough) Cycle 1	16.5 µg/mL Standard Deviation 8.80	118 µg/mL Standard Deviation 25.1
Observed Serum Concentration of Bemarituzumab at the End of the Dose Interval (Ctrough) Cycle 2	25.6 µg/mL Standard Deviation 10.6	131 µg/mL Standard Deviation 55.3

SECONDARY outcome

Timeframe: Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours after the end of infusion.

Population: Participants who received bemarituzumab with available AUC data

Area under the observed concentration-time curve from the time of dosing to Day 14 (0-336h) calculated by log-linear trapezoidal approximation.

Outcome measures

Outcome measures
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=7 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Area Under the Observed Concentration-time Curve From the Time of Dosing to Day 14 (AUC0-14)	556 μg*day/mL Standard Deviation 232	2350 μg*day/mL Standard Deviation 394

SECONDARY outcome

Timeframe: Cycle 1 day 1 at predose, 0.25, 4, 48, and 168 hours after end of infusion, and for participants in Cohort 2 day 8 at 0.25 and 4 hours after end of infusion.

Population: Participants who received bemarituzumab with available half-life data

Outcome measures

Outcome measures
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=3 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Terminal Half-life (t1/2) of Bemarituzumab	8.35 days Standard Deviation 3.36	4.23 days Standard Deviation 0.447

SECONDARY outcome

Timeframe: Samples were collected for ADA analysis predose on day 1 of Cycles 1, 2, 3, 7, and 10 and at 28 days following the last dose.

Population: The ADA-evaluable analysis set includes all enrolled participants who received at least 1 dose of bemarituzumab and had at least 1 ADA sample drawn at any timepoint with available ADA data.

Postbaseline treatment induced antidrug antibody (ADA) positive is defined as participants with * ADA negative at baseline and ADA positive at any postbaseline timepoint, or * ADA positive at baseline and ADA positive with titer of at least 4-fold of the baseline titer at one or more postbaseline timepoint.

Outcome measures

Outcome measures
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 Participants Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=9 Participants Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Number of Participants With Treatment Induced Anti-bemarituzumab Antibodies	0 Participants	0 Participants

Adverse Events

Bemarituzumab 6 mg/kg + mFOLFOX6

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Bemarituzumab 15 mg/kg + mFOLFOX6

Serious events: 4 serious events

Other events: 9 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Bemarituzumab 6 mg/kg + mFOLFOX6 n=3 participants at risk Participants received 6 mg/kg bemarituzumab administered Q2W and mFOLFOX6 chemotherapy administered Q2W until unacceptable toxicity, disease progression, or death.	Bemarituzumab 15 mg/kg + mFOLFOX6 n=9 participants at risk Participants received 15 mg/kg bemarituzumab administered Q2W with a single additional bemarituzumab 7.5 mg/kg dose on cycle 1 day 8. Participants also received mFOLFOX6 chemotherapy administered Q2W. Treatment continued until unacceptable toxicity, disease progression, or death.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/3 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.	11.1% 1/9 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.	11.1% 1/9 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.
Infections and infestations Septic shock	0.00% 0/3 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.	11.1% 1/9 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.	11.1% 1/9 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.	11.1% 1/9 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.	11.1% 1/9 • All-cause mortality: From enrollment to end of study; median (min, max) time on study was 19.4 (13.9, 22.4) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 28.6 (4.3, 49.6) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group. Adverse Events: From first dose of any study drug to 28 days after last dose; Actual median (min, max) duration of treatment emergent period was 19.3 (12.3, 22.3) weeks in Bemarituzumab 6 mg/kg + mFOLFOX6 and 19.4 (4.0, 35.4) weeks in Bemarituzumab 15 mg/kg + mFOLFOX6 group.

Other adverse events

Additional Information

Study Director

Amgen

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The CTA generally does not restrict an investigator's discussion of trial results after completion. Amgen has limited time to review material discussing trial results (up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control/approval of content. For multicenter studies, PI agrees not to publish results before first multi-center publication for at least 18 mo after study completion at all sites \& all analyses of data resulting from Study.
Publication restrictions are in place

Restriction type: OTHER