drugset / Trial / NCT05267470

A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)

NCT05267470 ↗

Phase 1 Terminated 74 enrolled Amgen
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.

Timeline

Start
2022-03-29
Primary completion
2024-05-28
Completion
2024-05-28

Outcome

Outcome not reported

Stopped (Business): “Business decision not due to safety concerns”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bemarituzumab Monoclonal antibody — Intravenous
Subject Nab-paclitaxel Small molecule — Intravenous
Subject Paclitaxel Small molecule — Intravenous
Background Carboplatin Small molecule — Intravenous
Background Docetaxel Small molecule — Intravenous
Background Pembrolizumab Monoclonal antibody — Intravenous