RecruitingPhase 1Phase 2NCT05669430

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

An Open-Label Phase 1/2A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Advanced and/or Refractory Solid Tumor Malignancies

Sponsor

GV20 Therapeutics

Enrollment

365 participants

Start Date

Mar 23, 2023

Study Type

INTERVENTIONAL

Conditions

Solid Tumor, Adult Cutaneous Melanoma Refractory Cancer Endometrial Carcinoma (EC)Squamous Head and Neck Carcinoma pMMR/MSS Adenocarcinoma of the Colon or Rectum

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental drug called GV20-0251, either alone or combined with pembrolizumab (an existing immunotherapy), in adults with advanced solid tumors (various cancers) that have stopped responding to standard treatments. GV20-0251 is designed to help the immune system better attack cancer cells. **You may be eligible if...** - You are 18 or older - You have advanced cancer confirmed by biopsy that has progressed despite prior treatment - You have tried standard therapies or are not eligible for them - You have at least one measurable tumor and are in reasonably good health (ECOG 0–1) - Your life expectancy is at least 12 weeks **You may NOT be eligible if...** - You have active autoimmune disease requiring treatment - You have uncontrolled brain metastases - You have active serious infections or are immunocompromised - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGV20-0251

Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy.

BIOLOGICALGV20-0251

GV20-0251 preliminary RP2D administered by IV infusion as monotherapy.

BIOLOGICALGV20-0251 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.

BIOLOGICALGV20-0251 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.

Locations(13)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Yale University

New Haven, Connecticut, United States

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida, United States

Community Health Network, Inc.

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Detroit, Michigan, United States

NYU Langone Health

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Verdi Oncology Tennessee, Scri Oncology Partners

Nashville, Tennessee, United States

Oncology Consultants, P.A.

Houston, Texas, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05669430

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