IGSF8 is an innate immune checkpoint and cancer immunotherapy target.
Yulong Li, Xiangyang Wu, Caibin Sheng...
https://pubmed.ncbi.nlm.nih.gov/38657602Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID05669430
An Open-Label Phase 1/2A Study of GV20-0251 Alone and With Pembrolizumab in Adults With Advanced or Refractory Solid Tumors
Led by GV20 Therapeutics · Updated on 2025-02-13
365
Participants Needed
13
Research Sites
37 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
Researchers are studying GV20-0251, a biological treatment, alone and combined with pembrolizumab for adults with advanced solid tumors that have not responded to standard treatments. This open-label Phase 1/2A trial aims to find safe doses and understand the treatment's effects on various tumor types, including endometrial carcinoma, head and neck carcinoma, melanoma, lung cancer, and certain colon or rectal cancers. The study has four parts: Part A uses a dose escalation method to find the best dose of GV20-0251 alone. Part B expands testing of this dose in different tumor groups. Part C tests GV20-0251 combined with pembrolizumab at increasing doses. Part D expands the combination treatment in more tumor groups. Treatments are given by intravenous infusions every three weeks, with dosing adjusted based on safety and response. Participants will undergo tumor biopsies before and during treatment when possible. Researchers will monitor safety, side effects, and how the drugs behave in the body, along with tumor responses using standard criteria over up to 24 months. The main outcomes include tumor response rates and adverse events. The study involves multiple visits for infusions, assessments, lab tests, and biopsies, with careful monitoring throughout the trial period.
CONDITIONS
Brief Title
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Participants 18 years of age or older
- Histologically confirmed advanced solid malignancy with progressive disease needing therapy
- Refractory or intolerant to standard therapies
- Must have received, be ineligible for, or decline standard of care therapy
- Measurable disease by RECIST version 1.1
- Documented disease progression if previously treated with checkpoint inhibitors
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks for Parts A and C, and 24 weeks for Parts B and D
- Willingness to provide fresh tumor biopsies before and during treatment if feasible
- Disease-free of other active or prior malignancies for at least 2 years
- Laboratory tests within required parameters
- Women of childbearing potential and men must agree to use adequate contraception
- Parts B, C, and D may include specific tumor types such as endometrial carcinoma, squamous head and neck carcinoma, cutaneous melanoma, non-small cell lung cancer, and proficient MMR/MSS adenocarcinoma of the colon or rectum
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 conditions needing chronic systemic steroids or immunosuppressants
- History of major organ or bone marrow transplant
- Symptomatic central nervous system malignancy or metastasis
- Serious nonmalignant diseases
- Pregnant or nursing women
- Treatment with PD-1 or similar immune modulators or major surgery before first study dose
- Receiving other investigational agents or recent investigational treatment within 4 weeks
- Recent anticancer treatments within 2 weeks before study dose
- Radiation for symptomatic lesions must be completed before study dose
- Liver metastases unless approved by the sponsor
- History of severe immune-related adverse events from prior cancer immunotherapy
- Additional progressing malignancies requiring active treatment within 2 years
- Radiation therapy to lung exceeding 30 Gy within 6 months before study dose (Parts C and D only)
- Severe hypersensitivity to pembrolizumab or its excipients (Parts C and D only)
- History or current pneumonitis or interstitial lung disease requiring steroids (Parts C and D only)
- Conditions or treatments that could interfere with study participation or results (Parts C and D only)
- Active substance abuse disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 months depending on treatment part and participant response
Participants receive GV20-0251 monotherapy or GV20-0251 in combination with pembrolizumab administered by intravenous infusion once every 3 weeks or twice every 3 weeks depending on the part of the study, to evaluate safety, tolerability, and anti-tumor activity.
Infusions every 3 weeks with visits corresponding to dosing schedule
Follow-up
Duration - Up to 24 months
Participants are monitored for overall survival, additional safety and tolerability, and long-term outcomes after treatment completion.
Periodic visits as scheduled by the study team following treatment
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
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Research Team
G
GV20 Therapeutics
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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