A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

365

Participants

Timeline

Start Date

March 23, 2023

Primary Completion Date

December 15, 2026

Study Completion Date

September 5, 2027

Conditions
Solid Tumor, AdultRefractory CancerEndometrial Carcinoma (EC)Squamous Head and Neck CarcinomapMMR/MSS Adenocarcinoma of the Colon or RectumCutaneous MelanomaNon-Small Cell Lung Cancer
Interventions
BIOLOGICAL

GV20-0251

Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.

BIOLOGICAL

GV20-0251

GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.

BIOLOGICAL

GV20-0251 and Pembrolizumab [KEYTRUDA®]

GV20-0251 administered by IV infusion at 10 mg/kg once every 3 weeks or at increasing doses up to the preliminary RP2D determined in Part A. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.

BIOLOGICAL

GV20-0251 and Pembrolizumab [KEYTRUDA®]

GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.

Trial Locations (13)

10016

RECRUITING

NYU Langone Health, New York

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

33916

NOT_YET_RECRUITING

Florida Cancer Specialists & Research Institute, LLC, Fort Myers

37203

NOT_YET_RECRUITING

Verdi Oncology Tennessee, Scri Oncology Partners, Nashville

46256

RECRUITING

Community Health Network, Inc., Indianapolis

48201

RECRUITING

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center, Detroit

77030

RECRUITING

Oncology Consultants, P.A., Houston

RECRUITING

The University of Texas M. D. Anderson Cancer Center, Houston

80218

NOT_YET_RECRUITING

HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE, Denver

90025

RECRUITING

The Angeles Clinic and Research Institute, Los Angeles

97239

RECRUITING

Oregon Health & Science University, Portland

06511

RECRUITING

Yale University, New Haven

02114

RECRUITING

Massachusetts General Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

GV20 Therapeutics

INDUSTRY