Actively Recruiting
A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors
Led by Suzhou Genhouse Bio Co., Ltd. · Updated on 2024-07-08
156
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
Sponsors
S
Suzhou Genhouse Bio Co., Ltd.
Lead Sponsor
Z
Zhejiang Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 18 years or older
- Able to understand the study and provide informed consent
- Able to follow study medication and procedures
- Phase Ia: Histological or cytological diagnosis of recurrent or metastatic advanced solid tumors with no effective standard treatment
- Phase Ib: Advanced solid tumors with TP53 mutation and whole-genome doubling (WGD+), no effective standard treatment
- Expected survival of at least 12 weeks
- ECOG performance status of 0 to 1
- At least one measurable lesion per RECIST 1.1
- Adequate organ function including blood counts, liver, kidney, coagulation, and heart function
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during and after the study
You will not qualify if you...
- Chemotherapy within 21 days or other anti-tumor treatments within 28 days before first dose
- Use of investigational drugs within 28 days before first dose
- Unresolved toxic effects from prior treatments above grade 1 except alopecia and fatigue
- Prolonged QT interval or significant heart rhythm abnormalities
- Active infections including hepatitis B, C, HIV (unless well-controlled), or syphilis
- Symptomatic or active central nervous system metastases not meeting specified criteria
- Uncontrolled severe infection, heart failure, other recent malignancies, or cancer-related complications
- History of poorly controlled hypertension or recent arterial thromboembolic events
- Significant malnutrition or tumor invasion of critical organs
- Allergy to GH2616 or its components
- Severe lung disease or history
- Use of strong inhibitors or inducers of P-glycoprotein or sensitive CYP3A4 substrates before dosing
- Pregnant or breastfeeding women
- History of organ or stem cell transplantation
- Recent major surgery or unhealed wounds
- Mental disorders under treatment
- Prior treatment with KIF18A inhibitor
- POLE gene hotspot mutations or hypermutator phenotype
- Any other conditions judged by the Investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Zhejiang, China
Actively Recruiting
Research Team
S
SHIYA CHEN, bachelor
CONTACT
Z
ZHENGBO SONG, Doctorate
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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