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

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor, Adult, Refractory Cancer, Endometrial Carcinoma (EC), Squamous Head and Neck Carcinoma, pMMR/MSS Adenocarcinoma of the Colon or Rectum, Cutaneous Melanoma, Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05669430

Run by

GV20 Therapeutics

People needed

365

Starts

2023-03-23

Expected to finish

2027-09-05

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 (WOCBP) and men must agree to use adequate contraception
• Parts B, C and D may include the following tumor types:
• Endometrial carcinoma
• Squamous head and neck carcinoma
• Cutaneous melanoma
• Non-small cell lung cancer
• Proficient MMR (pMMR)/MSS adenocarcinoma of the colon or rectum (Parts C and D only)
• Parts A, B, C and D Exclusion Criteria:
• Participant with acute leukemia or CLL (Parts A and B only)
• Participant with heart disease or unstable arrhythmia
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
• Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
• History of major organ transplant
• History of a bone marrow transplant

Where it is running

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

Full record on ClinicalTrials.gov

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