A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

Inclusion Criteria

• •1. Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed
• •2. Histologically or cytologically confirmed cancer of one of the following types, refractory to or relapsed after at least 1 prior standard therapeutic regimen in the advanced/metastatic setting, as specified below. If no standard of care therapies exist for the participant, or the participant cannot tolerate or refuses standard of care anticancer therapy, the participant may be allowed to participate on the study after discussion between the investigator and Amgen medical monitor. Participants who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving bemarituzumab are available prior to consenting to participate in the trial.
• •* head and neck squamous cell carcinoma: ≥ 1 line of therapy
• •* triple-negative breast cancer: ≥ 2 lines of therapy
• •* Intrahepatic cholangiocarcinoma ≥ 1 line of therapy
• •* lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor, and targeted therapy
• •* platinum resistant ovarian epithelial cell carcinoma, including fallopian tube cancers and primary peritoneal cancers, defined as progression during or within 6 months of a platinum containing regimen: ≥ 1 line of therapy
• •* endometrial adenocarcinoma: ≥ 1 line of therapy
• •* cervical carcinoma: ≥ 1 line of therapy
• •* other solid tumors: ≥ 1 line of therapy
• •3. Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)
• •4. Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing
• •5. Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •7. Adequate organ function as determined per protocol.