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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.
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
Conditions
Interventions
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