A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors
NCT06329206 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2024-07-08
Summary
This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics (PD) and preliminary efficacy of GH2616 Tablet in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).
Conditions
Interventions
- DRUG
-
GH2616 Tablets
GH2616 tablets will be given orally
Sponsors & Collaborators
-
Zhejiang Cancer Hospital
collaborator OTHER -
Henan Cancer Hospital
collaborator OTHER_GOV -
Hubei Cancer Hospital
collaborator OTHER -
The First Affiliated Hospital of Zhengzhou University
collaborator OTHER -
Suzhou Genhouse Bio Co., Ltd.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-20
- Primary Completion
- 2026-04-25
- Completion
- 2026-09-01
- FDA Drug
- Yes
Countries
- China
Study Locations
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