P1, N=180, Active, not recruiting, Amgen | Phase classification: P1b --> P1

P1, N=80, Recruiting, Amgen | Trial primary completion date: Nov 2026 --> Mar 2026

Phase III and Ib/III trials of the FGFR2-targeted antibody bemarituzumab for G/GEJ cancer overexpressing FGFR2b are ongoing based on the promising result in a phase II trial, especially in cases with an FGFR2b positivity of ≥ 10%...CLDN18.2 is expressed in some G/GEJ tumors but lacks oncogenic driver potential, and the CLDN18.2-targeted antibody zolbetuximab prolonged the survival of CLDN18.2-positive G/GEJ cancer patients in phase III trials...Similarly, targeting of nondriver molecules such as DKK1, TROP2, and CEACAM5 is under investigation in early-stage clinical trials. This shift in focus from target molecules with driver potential to markers for precise drug delivery should increase the number of possible targets in G/GEJ cancer.

P1, N=80, Recruiting, Amgen | Trial completion date: Sep 2027 --> Apr 2028 | Trial primary completion date: May 2026 --> Nov 2026

Other targeted agents, such as bemarituzumab and DKN-01, are under active investigation. As new agents are incorporated into the treatment continuum, the questions of biomarker overlap, tumor heterogeneity, and toxicity management will need to be addressed.

P1/2, N=303, Recruiting, Amgen | Trial completion date: Jul 2026 --> Jun 2027 | Trial primary completion date: Oct 2024 --> Sep 2025

In FGFR2b-positive advanced GC, the combination of bemarituzumab-mFOLFOX6 led to numerically longer median PFS and OS compared with mFOLFOX6 alone. Efficacy was more pronounced with FGFR2b overexpression in ≥ 10% of tumor cells. Confirmatory phase 3 trials are ongoing (NCT05052801, NCT05111626).

P1, N=80, Recruiting, Amgen | Phase classification: P1b --> P1 | N=30 --> 80