Clinical Trial

GH55 for Advanced Cancers With MAPK Mutations: A Study on Safety and Early Results

Unknown Phase 1/2
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Record status
This record was last updated July 8, 2024 (before its estimated May 26, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors. This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06310382
Lead Sponsor Suzhou Genhouse Bio Co., Ltd.
Collaborators: Shanghai East Hospital, Shandong Tumor Hospital
Conditions Advanced Solid Tumors With MAPK Signal Pathway Mutations
Enrollment 110 participants
Start Date 2022-12-07
Primary Completion 2025-05-26 (estimated)
Study Completion 2025-08-04 (estimated)
Updated on ClinicalTrials.gov 2024-07-08