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Recently added Catalysts

bemarituzumab, paclitaxel, ramucirumab

Phase 2

Metastatic Gastro-esophageal Adenocarcinoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Jan 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment126
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06680622Bemarituzumab in FGFR2b+ Patients With Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction, Who Failed at Least One Prior Line of Palliative ChemotherapyPHASE2 ACTIVE NOT_RECRUITING 126Mar 3, 2025Mar 1, 2028Jan 7, 202635 Germany
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Study Endpoints
Primary Endpoints
Objective response rate (ORR)
from date of enrollment to date of last response acc. to RECIST v1.1 or death due to any cause, through study completion, up to 33 months

Objective response rate (ORR), defined as proportion of subjects with a complete response (CR) or partial response (PR) acc. to RECIST v1.1, for each cohort (cohort 1 - bemarituzumab plus irinotecan, cohort 2 - bemarituzumab plus paclitaxel and ramucirumab, cohort 3 - bemarituzumab plus trifluridine/tipiracil).

Secondary Endpoints
Progression-free survival (PFS)
from date of enrollment to date of progression acc. to RECIST v1.1 or death due to any cause, through study completion, up to 33 months
Overall survival (OS)
time from date of enrollment to date of death due to any cause, through study completion, up to 33 months
Disease control rate (DCR)
time from date of enrollment to date of last tumor assessment acc. to RECIST 1.1 or death due to any cause, through study completion, up to 33 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALbemarituzumab plus SOC treatment with irinotecan
Cohort 2EXPERIMENTALbemarituzumab plus SOC treatment with paclitaxel plus ramucirumab
Cohort 3EXPERIMENTALbemarituzumab plus SOC treatment with trifluridine/tipiracil
Interventions
NameTypeDescription
bemarituzumab, paclitaxel, ramucirumabDRUGCohort 2 will receive bemarituzumab plus SOC treatment with paclitaxel and ramucirumab
bemarituzumab, irinotecanDRUGCohort 1 will receive bemarituzumab plus SOC treatment with irinotecan
bemarituzumab, trifluridine/tipiracilDRUGCohort 3 will receive bemarituzumab plus SOC treatment with trifluridine/tipiracil
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: 1. Patient provide signed informed consent form. 2. Patient is ≥ 18 years at the time of given informed consent. 3. Patient has been diagnosed with histologically proven advanced or metastatic adenocarcinoma of the stomach or of the gastroesophageal junction, which is not amenab...

Countries:Germany
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