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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGV20-0251 and GV20-0251

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 13, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?13 U.S. locations

Locations may change over time.

Who runs it?GV20 Therapeutics

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: GV20 Therapeutics
Interventions being studied: Biological: GV20-0251; Biological: GV20-0251; Biological: GV20-0251 and Pembrolizumab [KEYTRUDA®]; Biological: GV20-0251 and Pembrolizumab [KEYTRUDA®]

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Resistant or refractory→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion 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
Symptomatic central nervous system (CNS) malignancy or metastasis
Serious nonmalignant disease
Pregnant or nursing women
Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication
Participants who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication
Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication
Radiation for symptomatic lesions must have been completed prior to the first dose of study medication
Participants with liver metastases unless approved by the Sponsor
Any history of an immune related ≥ Grade 3 AE attributed to prior cancer immunotherapy
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1
Has received radiation therapy to the lung that is higher than 30 Gy within 6 months prior to C1D1 for NSCLC (Parts C and D only)
Has a known additional malignancy that is progressing or has required active treatment within the past 2 years from C1D1 (Parts C and D only)
Has severe hypersensitivity ( ≥ Grade 3) to Pembrolizumab and/or any of its excipients (Parts C and D only)
Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease (Parts C and D only)
Has a condition, therapy, laboratory abnormality, or circumstance that could confound study results or interfere with full participation, making it unsuitable for the participant, as determined by the treating Investigator (Parts C and D only)
Active substance abuse

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

The Angeles Clinic and Research InstituteLos Angeles, California
HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONEDenver, Colorado
Yale UniversityNew Haven, Connecticut
Florida Cancer Specialists & Research Institute, LLCFort Myers, Florida
Community Health Network, Inc.Indianapolis, Indiana
Massachusetts General HospitalBoston, Massachusetts
Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer CenterDetroit, Michigan
NYU Langone HealthNew York, New York
Oregon Health & Science UniversityPortland, Oregon
Verdi Oncology Tennessee, Scri Oncology PartnersNashville, Tennessee
Oncology Consultants, P.A.Houston, Texas
The University of Texas M. D. Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2025. Always confirm current availability with the study team.

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