A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies (NCT05669430)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participants ≥18 years of age
2. Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy
3. Refractory or intolerant to standard therapy(ies)
4. Must have received, be not eligible or decline standard of care therapy
5. Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
6. For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
7. ECOG performance status of 0 or 1
8. Life expectancy of ≥ 12 weeks in Parts A and C and ≥ 24 weeks in Parts B and D
9. 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
10. Disease-free of active second/secondary or prior malignancies for ≥ 2 years
11. Laboratory test results within the required parameters
12. Women of child bearing potential (WOCBP) and men must agree to use adequate contraception

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (13 Sites)

• The Angeles Clinic and Research Institute — Los Angeles, California
• HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE — Denver, Colorado
• Yale University — New Haven, Connecticut
• Florida Cancer Specialists & Research Institute, LLC — Fort Myers, Florida
• Community Health Network, Inc. — Indianapolis, Indiana
• Massachusetts General Hospital — Boston, Massachusetts
• Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center — Detroit, Michigan
• NYU Langone Health — New York, New York
• Oregon Health & Science University — Portland, Oregon
• Verdi Oncology Tennessee, Scri Oncology Partners — Nashville, Tennessee
• Oncology Consultants, P.A. — Houston, Texas
• The University of Texas M. D. Anderson Cancer Center — Houston, Texas
• Virginia Cancer Specialists — Fairfax, Virginia

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.