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RECRUITING
NCT06796699
PHASE1

A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors(G-MAP 101)

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 to 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).The Part Ib dose expansion study includes adult cohort and adolescent cohort (12-17 years of age).

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

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-03-07

Completion Date

2028-02-29

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DRUG

GH56 Capsule

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

Locations (25)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The Second People's Hospital of Guiyang

Guiyang, Guizhou, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Shandong Medical and Pharmaceutical University Hospital

Binzhou, Shandong, 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

The Second People's Hospital of Yibin

Yibin, Sichuan, China

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Uygur Autonomous Region, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China