Actively Recruiting
A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors
Led by Suzhou Genhouse Bio Co., Ltd. · Updated on 2025-03-28
90
Participants Needed
4
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase Ia/Ib Clinical Study of GH56 Capsules in Subjects With MTAP-Deleted Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate, understand and sign informed consent, and comply with study visits and procedures
- Men or women 18 years or older
- Diagnosed with MTAP-Deleted Advanced Solid Tumors
- Have at least one measurable tumor lesion by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Expected survival of at least 12 weeks
- Adequate organ function and laboratory test results
- Negative serum pregnancy test for females of childbearing potential within 7 days prior to first dose
- Agree to use effective contraception from consent signing through 6 months after last dose if of childbearing potential
You will not qualify if you...
- Not recovered from prior surgery or had major surgery within 4 weeks before first dose
- Known or suspected allergy to GH56 or its components
- Received anti-tumor agents or therapies within 28 days prior to first GH56 dose
- Have symptomatic or active progressive central nervous system metastases
- Difficulty swallowing or history of gastrointestinal surgery affecting drug absorption
- Had another malignant tumor within 5 years prior to first GH56 dose except certain localized cancers
- Uncontrolled or significant cardiovascular disease
- Positive for hepatitis B, hepatitis C, or HIV infections
- Any condition deemed inappropriate by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Not Yet Recruiting
3
Shanghai GoBroad Caner Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality, China, 201200
Not Yet Recruiting
4
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 30009
Not Yet Recruiting
Research Team
Y
Yiming Zhou, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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