A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.

Sponsor
GV20 Therapeutics
Study ID
NCT07623642
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • GV20-0251 — DRUG
    GV20-0251 10/20 mg/kg or SRC-recommended dose in combination with anti-PD-1, Q3W; Part B: RP2D + standard dose anti-PD-1, Q3W.
  • anti-PD-1 monoclonal antibodies — DRUG
    anti-PD-1 monoclonal antibodies 200 mg IV Q3W; C1D1 infusion ≥ 60 min, subsequent infusions may be shortened to ≥ 30 min; administered prior to GV20-0251.

Study Details

This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.

Key Dates

First listed
Jun 3, 2026
Start date
Jun 2, 2026
Status verified
Jun 2026
Primary completion
Jun 15, 2028
Completion
Aug 15, 2029

Study Design

Enrollment
227 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GV20-0251 + Anti-PD-1 Monoclonal Antibody Combination Therapy
    All participants receive GV20-0251 by intravenous (IV) infusion every 3 weeks (Q3W) in combination with anti-PD-1 monoclonal antibodies 200 mg IV Q3W. In Part A (Safety Bridging), GV20-0251 is administered at 10 mg/kg, 20 mg/kg, or an alternative SRC-determined dose in sequential dose cohorts to determine the Recommended Phase 2 Dose (RP2D). In Part B (Phase 2 Pivotal), GV20-0251 is administered at the RP2D across multiple tumor-type cohorts.

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) and Treatment-Emergent Adverse Events (TEAEs) in Combination with Anti-PD-1 Monoclonal Antibody [ Time Frame: From Cycle 1 Day 1 dosing (each cycle is 21 days) through 30 days after end of treatment, up to 24 months ]

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