NCT07070518

Study of GV20-0251 in Participants With Solid Tumor Malignancies

An Open-Label Phase 1/2A Study of GV20-0251 in Participants With Advanced and/or Refractory Solid Tumor Malignancies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: GV20 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase 1/2A non-randomized, open-label, multi-center study to be conducted in 2 parts (A and B). Part A is a safety run-in portion. A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D). In Part B, the Simon 2-stage design will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D across multiple expansion cohorts involving eligible participants.

Conditions

• Solid Tumor Cancer
• Adult Refractory Cancer
• Endometrial Carcinoma (EC)
• Squamous Head and Neck Carcinoma
• pMMR/MSS Adenocarcinoma of the Colon or Rectum
• Non-Small Cell Lung Cancer
• Melanoma
• HCC - Hepatocellular Carcinoma
• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GV20-0251	Part 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

Timeline

• Start date: 2025-07-11
• Primary completion: 2027-07-16
• Completion: 2028-09-16
• First posted: 2025-07-17
• Last updated: 2025-12-03

Locations

3 sites across 1 country: China