Clinical Trial

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

Terminated Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
The adjustment of the sponsor's R\&D strategy.
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).
Protocol Amendment History 5 changes
critical Trial status changed: Not Yet Recruiting → Terminated 2026-08-07
critical Trial terminated: The adjustment of the sponsor's R\&D strategy. 2026-08-07
notable Enrollment reduced: 240 -> 11 participants 2026-08-07
notable Primary completion moved earlier: 2025-11 -> 2025-05-23 2026-08-07
minor Completion moved earlier: 2026-12 -> 2025-05-23 2026-08-07
Trial Details
NCT Number NCT06516926
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions HER2-expressing or -Mutated Unresectable or Metastatic Solid Tumors
Enrollment 11 participants
Start Date 2024-08-08
Primary Completion 2025-05-23 (estimated)
Study Completion 2025-05-23 (estimated)
Updated on ClinicalTrials.gov 2026-08-06