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RECRUITING
NCT06796699
PHASE1

A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors

Sponsor: Suzhou Genhouse Bio Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, single-arm, open-label, dose-escalation, dose-expansion study to evaluate the safety, tolerability, PK/PD, and preliminary anti-tumor activity of GH56 Capsule in subjects with advanced solid tumors who have failed or are intolerant in standard treatment, or have no standard therapy. The clinical trial will be carried out in two parts: phase Ia study (dose escalation study) and phase Ib (dose expansion study).

Official title: A Multi-center, Single-Arm, Open-Label Phase Ia/Ib Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-03-07

Completion Date

2028-02-29

Last Updated

2025-03-28

Healthy Volunteers

No

Interventions

DRUG

GH56 Capsule

GH56 capsule for oral administration at specified doses on scheduled days.

Locations (4)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai GoBroad Caner Hospital China Pharmaceutical University

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China