A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
Start Date
3/23/2023
Completion Date
9/5/2027
Summary
This is a Phase 1/2A 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 four parts (Parts A, B, C and D). In Part A, 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 Bayesian optimal design for Phase II (BOP2) 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. In Part C, the Bayesian optimal interval (BOIN) design will be employed to evaluate the safety and tolerability of GV20-0251 in combination with Pembrolizumab, and to determine the MTD or the preliminary RP2D of this combination. In Part D, BOP2 will be applied to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 in combination with Pembrolizumab at the preliminary RP2D across multiple expansion cohorts involving eligible participants.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
GV20-0251
GV20-0251
GV20-0251 and Pembrolizumab [KEYTRUDA®]
GV20-0251 and Pembrolizumab [KEYTRUDA®]
Conditions
Locations
The Angeles Clinic and Research Institute
Los Angeles, California 90025
United States
HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
United States
Yale University
New Haven, Connecticut 06511
United States
Florida Cancer Specialists & Research Institute, LLC
Fort Myers, Florida 33916
United States
Community Health Network, Inc.
Indianapolis, Indiana 46256
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan 48201
United States
NYU Langone Health
New York, New York 10016
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
Verdi Oncology Tennessee, Scri Oncology Partners
Nashville, Tennessee 37203
United States
Oncology Consultants, P.A.
Houston, Texas 77030
United States
The University of Texas M. D. Anderson Cancer Center
Houston, Texas 77030
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States