Actively Recruiting
A Phase 1/2 Study of GW5282 in Participants With Advanced Solid Tumors
Led by Dizal Pharmaceuticals · Updated on 2026-02-11
203
Participants Needed
3
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1/2, open-label, multicenter study assessing the safety, tolerability, pharmacokinetics and efficacy of GW5282 in participants with locally advanced or metastatic solid tumors. This study comprised of a dose escalation phase to determine the MTD and the RP2D and a dose expansion phase to further explore the safety, PK and efficacy of GW5282.
CONDITIONS
Official Title
A Phase 1/2 Study of GW5282 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must provide signed, dated informed consent before any study procedures.
- Male and female participants must be 18 years or older at consent.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors with prior standard care failure.
- Life expectancy of at least 3 months.
- At least one measurable lesion according to RECIST 1.1.
- Available tumor tissue samples from fresh biopsy or archived specimens.
- Adequate organ and bone marrow function.
- Ability to comply with study medication and follow-up requirements.
- Male participants with female partners of childbearing potential must agree to use contraception and avoid sperm donation during treatment and for 6 months after.
- Female participants must use adequate contraception during treatment and for 3 months after, have a negative pregnancy test before starting, or meet postmenopausal or surgical sterilization criteria.
You will not qualify if you...
- Any unresolved adverse event above grade 1 (except alopecia, anemia, neutropenia, thrombocytopenia) before starting treatment.
- Known active central nervous system metastases, carcinomatous meningitis, or spinal cord compression.
- Prior treatment with GW5282 or other EZH pathway inhibitors.
- Received cytotoxic chemotherapy, investigational drugs, or other anticancer drugs (excluding macromolecular drugs) within 7 days or 5 half-lives before treatment.
- Received macromolecular drugs like immunotherapy or monoclonal antibodies within 28 days prior.
- Major surgery (except vascular access) or severe trauma within 4 weeks before treatment.
- Radiation to alleviate symptoms within 7 days or extensive radiation to bone marrow within 28 days before treatment.
- Received live-attenuated or viral vector vaccines within 4 weeks before treatment.
- Active infections.
- History of stroke or brain bleeding within 6 months before treatment.
- History or active interstitial lung disease or immunotherapy-related pneumonitis.
- Uncontrolled systemic diseases including uncontrolled hypertension or active bleeding.
- Investigator judgment of inability to comply with study requirements.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Sherry Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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