NCT05669430 · GV20 Therapeutics
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
What this study is about
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 the usual treatment.
View original scientific description
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.
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.
Primary outcome measures
Objective Response Rate ORR per RECIST version 1.1 (Parts B and D)
Time frame: 12 months
ORR
Percentage of Participants With Adverse Events (Parts A and C)
Time frame: 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants ≥18 years of age
- Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy
- Refractory or intolerant to standard therapy(ies)
- Must have received, be not eligible or decline standard of care therapy
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
- For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
- ECOG performance status of 0 or 1
- Life expectancy of ≥ 12 weeks in Parts A and C and ≥ 24 weeks in Parts B and D
- Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment (Parts A, B, C and D) and on-treatment (Parts A and B), if clinically feasible
- Disease-free of active second/secondary or prior malignancies for ≥ 2 years
- Laboratory test results within the required parameters
- Women of child bearing potential (WOCB
Where
- Los Angeles, California
- Denver, Colorado
- New Haven, Connecticut
- Fort Myers, Florida
- Indianapolis, Indiana
- Boston, Massachusetts
- Detroit, Michigan
- New York, New York
- Portland, Oregon
- Nashville, Tennessee
- Houston, Texas
- Fairfax, Virginia
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2025 · Source of record for eligibility and locations