Recruiting
Phase 1
Phase 2

GV20-0251, Pembrolizumab

Sponsor:

GV20 Therapeutics

Code:

NCT05669430

Conditions

Solid Tumor, Adult

Refractory Cancer

Endometrial Carcinoma (EC)

Squamous Head and Neck Carcinoma

pMMR/MSS Adenocarcinoma of the Colon or Rectum

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GV20-0251

GV20-0251

GV20-0251 and Pembrolizumab [KEYTRUDA®]

GV20-0251 and Pembrolizumab [KEYTRUDA®]

Study Details

Brief 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.

Conditions

Solid Tumor, Adult

Refractory Cancer

Endometrial Carcinoma (EC)

Squamous Head and Neck Carcinoma

pMMR/MSS Adenocarcinoma of the Colon or Rectum

Study ID

NCT05669430

Start date

Mar 23, 2023

Status verified date

Feb, 2025

Completion date

Sep 5, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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 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
  • 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

Study Design

Enrollment

365 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A - Dose Escalation in up to 7 dose levels

A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).

experimental: Part B - Multiple Expansion Cohorts in up to 4 tumor indications

The Bayesian optimal design for Phase II (BOP2) will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D in up to 4 expansion cohorts involving eligible participants.

experimental: Part C - GV20-0251 in Combination with Pembrolizumab Dose Escalation in 2-4 dose levels

The Bayesian optimal interval (BOIN) design will be employed to evaluate the safety and tolerability of GV20-0251 in combination with pembrolizumab, and to determine the MTD or the preliminary RP2D of this combination in selected tumor indications.

experimental: Part D - GV20-0251 in Combination with Pembrolizumab Dose Expansion in up to 5 indications

The BOP2 will be applied to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 in combination with pembrolizumab at the preliminary RP2D in up to 5 expansion cohorts involving eligible participants.

Interventions

GV20-0251

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

GV20-0251

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

GV20-0251 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.

GV20-0251 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.

Primary outcome measure

  • Objective Response Rate ORR per RECIST version 1.1 (Parts B and D) [ Time Frame: 12 months ]
  • Percentage of Participants With Adverse Events (Parts A and C) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

GV20 Therapeutics

617-256-2846clinicaltrials@gv20tx.com

Locations

The Angeles Clinic and Research Institute

Recruiting

Los Angeles, California, United States, 90025

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Kristopher Wentzel, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Patricia LoRusso, DO

Community Health Network, Inc.

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Bert O'Neil, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Justin Gainor, MD

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Recruiting

Detroit, Michigan, United States, 48201

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

M. Najeeb Al Hallak, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Janice Mehnert, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Shivaani Kummar, MD

Oncology Consultants, P.A.

Recruiting

Houston, Texas, United States, 77030

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Jose Peguero, MD

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Aung Naing, MD

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

GV20 Therapeutics

clinicaltrials@gv20tx.com

Principal Investigator:

Alexander Spira, MD

More Information

Sponsor

GV20 Therapeutics

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Keywords

  • GV20-0251

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GV20 Therapeutics on 2025-02-13.