SHR-4602 for Injection in Subjects With HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors

Summary

This is an open-label, randomized, multi-center phase II study to evaluate the safety, tolerability, PK, and efficacy of SHR-4602 monotherapy in subjects with HER2-expressing or -mutated unresectable or metastatic solid tumors. During the study, a safety monitoring committee (SMC), consisting of the principal investigator, sponsor representative, etc., will be established to review data from the study regarding safety, PK, efficacy, etc. The SMC will make decisions on study-related issues. The study includes a screening period (begins when the informed consent form (ICF) is signed and ends at the first dose), a treatment period (from the first dose to the last dose), and a follow-up period (end-of-treatment safety follow-up).

Timeline

Start

2024-08

Primary completion

2025-11

Completion

2026-12

Drugs

Indications

No indication recorded.