Study of GV20-0251 in Participants With Solid Tumor Malignancies
- Sponsor
- GV20 Therapeutics
- Study ID
- NCT07070518
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Adult Refractory Cancer
- Endometrial Carcinoma (EC)
- HCC - Hepatocellular Carcinoma
- Melanoma
- Non-Small Cell Lung Cancer
- Small Cell Lung Cancer
- Solid Tumor Cancer
- Squamous Head and Neck Carcinoma
- pMMR/MSS Adenocarcinoma of the Colon or Rectum
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- GV20-0251 — DRUGPart A: Increasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks Part B: GV20-0251 preliminary RP2D administered by IV infusion once every 3 weeks
Study Details
This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.
Key Dates
- First listed
- Jul 17, 2025
- Start date
- Jul 11, 2025
- Status verified
- Dec 2025
- Primary completion
- Jul 16, 2027
- Completion
- Sep 16, 2028
Study Design
- Enrollment
- 350 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: GV20-0251
Primary Outcome Measure
Evaluate anti-tumor activities with GV20-0251 [ Time Frame: From Cycle 1 Day 1 dosing (each cycle is 21 days) until disease progression or end of study (whichever occurs first, up to 24 months) ]
Central Contacts
- Shanghai Xunbaihui Biotechnology+8615800557307
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