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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
365
Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.
GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.
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.
GV20-0251 administered by IV infusion at preliminary RP2D from Part C. 200 mg pembrolizumab administered by IV infusion once every 3 weeks.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
RECRUITINGHealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
NOT_YET_RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGFlorida Cancer Specialists & Research Institute, LLC
Fort Myers, Florida, United States
NOT_YET_RECRUITINGCommunity Health Network, Inc.
Indianapolis, Indiana, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGBarbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGOregon Health & Science University
Portland, Oregon, United States
RECRUITINGVerdi Oncology Tennessee, Scri Oncology Partners
Nashville, Tennessee, United States
NOT_YET_RECRUITING...and 3 more locations
Objective Response Rate ORR per RECIST version 1.1 (Parts B and D)
ORR
Time frame: 12 months
Percentage of Participants With Adverse Events (Parts A and C)
Time frame: 12 months
Overall Survival (Parts B and D)
OS
Time frame: 24 months
Additional safety and tolerability
TEAEs per NCI CTCAE version 5.0
Time frame: 24 months
Cmax of GV20-0251
Maximum concentration
Time frame: 12 months
Tmax of GV20-0251
Time to peak drug concentration
Time frame: 12 months
T1/2
Terminal half-life of GV20-0251
Time frame: 12 months
AUC
Area under the curve
Time frame: 12 months
ADAs
Specification and quantification of anti-drug antibodies
Time frame: 12 months
nADAs
Neutralizing anti-drug antibodies
Time frame: 12 months
DCR
Disease Control Rate is the percentage of participants with stable disease, complete response or partial response among all response evaluable participants
Time frame: 24 months
DoR
Duration of Response is the time from first CR/PR to the date of PD or death.
Time frame: 24 months
PFS
Progression Free Survival is the duration from the first dose to PD/death
Time frame: 24 months
ORR (Parts A and C)
Percentage of participants with complete response or partial response among all response evaluable participants
Time frame: 24 months
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