Actively Recruiting
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
Led by GV20 Therapeutics · Updated on 2025-02-13
365
Participants Needed
13
Research Sites
232 weeks
Total Duration
On this page
Sponsors
G
GV20 Therapeutics
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial 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 standard of care.
CONDITIONS
Official Title
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older
- Histologically confirmed advanced solid malignancy with progressive disease requiring therapy
- Refractory or intolerant to standard therapies
- Have received, are not eligible for, or decline standard of care therapy
- Measurable disease per RECIST version 1.1
- Documented disease progression if previously treated with a checkpoint inhibitor
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks for Parts A and C and at least 24 weeks for Parts B and D
- Willing to provide fresh tumor biopsy before treatment and during treatment if clinically feasible
- No active second or prior malignancies for at least 2 years
- Laboratory test results within required parameters
- Women of childbearing potential and men must use adequate contraception
- Specific tumor types allowed in Parts B, C, and D including endometrial carcinoma, squamous head and neck carcinoma, cutaneous melanoma, non-small cell lung cancer, and proficient MMR/MSS adenocarcinoma of colon or rectum (Parts C and D only)
You will not qualify if you...
- Acute leukemia or chronic lymphocytic leukemia (Parts A and B only)
- Heart disease or unstable arrhythmia
- Active, uncontrolled infections requiring systemic therapy
- Active autoimmune disease or medical conditions requiring chronic systemic steroid or immunosuppressive therapy
- History of major organ or bone marrow transplant
- Symptomatic central nervous system malignancy or metastasis
- Serious nonmalignant disease
- Pregnant or nursing women
- Treatment with PD-1 or similar immune modulators or major surgery before first study dose
- Current participation in other investigational drug trials or investigational drug use within 4 weeks before first study dose
- Anticancer treatment within 2 weeks before first study dose
- Radiation for symptomatic lesions not completed before first study dose
- Liver metastases unless approved by sponsor
- History of immune-related Grade 3 or higher adverse events from prior cancer immunotherapy
- Additional progressing malignancy or active treatment within past 2 years
- Radiation to lung exceeding 30 Gy within 6 months before first study dose (Parts C and D only)
- Severe hypersensitivity to Pembrolizumab or its components (Parts C and D only)
- History or current pneumonitis or interstitial lung disease requiring steroids (Parts C and D only)
- Any condition or circumstance that could interfere with study participation or results (Parts C and D only)
- Active substance abuse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
2
HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Not Yet Recruiting
3
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
4
Florida Cancer Specialists & Research Institute, LLC
Fort Myers, Florida, United States, 33916
Not Yet Recruiting
5
Community Health Network, Inc.
Indianapolis, Indiana, United States, 46256
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Actively Recruiting
8
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
9
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
10
Verdi Oncology Tennessee, Scri Oncology Partners
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
11
Oncology Consultants, P.A.
Houston, Texas, United States, 77030
Actively Recruiting
12
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
G
GV20 Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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