Product Description
Bemarituzumab is currently being evaluated in combination with chemotherapy in a phase III trial as front-line therapy for patients with high FGFR2b-overexpressing advanced-stage GEA. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/32167861/)
Mechanisms of Action: FGFR2 Antagonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: Breakthrough Therapy - Gastrointestinal Cancer *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Amgen
Company Location: Western America
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 15
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Amgen presented P3 Gastrointestinal Cancer results on 2025-06-30 for Bemarituzumab
Highest Development Phases
Phase 3: Esophageal Cancer
Phase 2: Cervical Cancer|Cholangiocarcinoma|Endometrial Cancer|Head and Neck Cancer|Lung Cancer|Oncology Solid Tumor Unspecified|Ovarian Cancer|Squamous Cell Carcinoma|Triple Negative Breast Cancer
Phase 1: Non-Small-Cell Lung Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05322577 |
FORTITUDE-103 | P2 |
Active, not recruiting |
Esophageal Cancer|Gastrointestinal Cancer |
2025-11-21 |
12% |
2025-12-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
jRCT2031220301 |
jRCT2031220301 | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2026-09-25 |
|||
NCT05325866 |
FORTITUDE-301 | P2 |
Completed |
Cholangiocarcinoma|Adenocarcinoma|Head and Neck Cancer|Cervical Cancer|Endometrial Cancer|Triple Negative Breast Cancer|Lung Cancer|Ovarian Cancer|Squamous Cell Carcinoma |
2026-01-28 |
12% |
2026-02-05 |
Primary Endpoints |
jRCT2051220022 |
jRCT2051220022 | P1 |
Recruiting |
Non-Small-Cell Lung Cancer |
2025-07-11 |
|||
NCT06680622 |
BEMARA | P2 |
Active, not recruiting |
Adenocarcinoma|Esophageal Cancer |
2027-09-01 |
12% |
2026-01-08 |
Primary Endpoints |
2023-505455-44-00 |
20210104 | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2026-09-28 |
2025-05-02 |
Treatments |
|
jRCT2031210669 |
jRCT2031210669 | P3 |
Recruiting |
Adenocarcinoma|Gastrointestinal Cancer|Esophageal Cancer |
2027-01-26 |
|||
2023-505458-16-00 |
20210098 | P3 |
Active, not recruiting |
Esophageal Cancer|Gastrointestinal Cancer |
2027-01-04 |
2025-05-02 |
||
NCT05111626 |
FORTITUDE-102 | P3 |
Active, not recruiting |
Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer |
2025-10-14 |
57% |
2025-12-16 |
Primary Completion Date|Primary Endpoints |
2023-505457-40-00 |
20210096 | P3 |
Active, not recruiting |
Esophageal Cancer|Gastrointestinal Cancer |
2025-08-18 |
2025-05-02 |
Treatments |
|
jRCT2031220049 |
jRCT2031220049 | P3 |
Recruiting |
Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer |
2025-08-18 |
|||
NCT05052801 |
FORTITUDE-101 | P3 |
Active, not recruiting |
Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer |
2025-06-20 |
65% |
2025-07-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
jRCT2041220013 |
jRCT2041220013 | P1 |
Recruiting |
Esophageal Cancer|Gastrointestinal Cancer |
2025-05-03 |
|||
CTR20231087 |
CTR20231087 | P1 |
Active, not recruiting |
Adenocarcinoma|Esophageal Cancer|Gastrointestinal Cancer |
None |
2025-04-29 |
Patient Enrollment|Start Date|Treatments|Trial Status |
|
2024-512484-31-00 |
2024-512484-31-00 | P2 |
Recruiting |
Esophageal Cancer|Adenocarcinoma|Gastrointestinal Cancer |
2028-03-31 |
12% |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/06/2025 |
News Article |
Zai Lab Announces Third Quarter 2025 Financial Results and Recent Corporate Updates |
|
08/07/2025 |
News Article |
Zai Lab Announces Second Quarter 2025 Financial Results and Recent Corporate Updates |
|
08/06/2025 |
News Article |
Clinical Progress in Rare Disease Signals Long-Term Revenue Potential for Innovators |
|
07/16/2025 |
News Article |
Cancer Pipeline Milestones Coming Fast as Regulators Revisit Research Priorities |
|
06/01/2024 |
PubMed |
Targeted Agents in Esophagogastric Cancer Beyond Human Epidermal Growth Factor Receptor-2. |
|
04/17/2024 |
PubMed |
New therapeutic target molecules for gastric and gastroesophageal junction cancer. |
|
04/01/2024 |
PubMed |
FGFR-targeted therapeutics: clinical activity, mechanisms of resistance and new directions. |