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NCT05669430 | RECRUITING | Solid Tumor, Adult

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

GV20 Therapeutics

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.

Condition or disease

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

Intervention/treatment

GV20-0251

GV20-0251

GV20-0251 and Pembrolizumab [KEYTRUDA®]

GV20-0251 and Pembrolizumab [KEYTRUDA®]

Phase

PHASE1

PHASE2

Detailed Description:

This is a Phase 1/2A non-randomized, open label, multi-center study to be conducted in four parts (Parts A, B, C and D). In Part A, 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). In Part B, 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 across multiple expansion cohorts involving eligible participants. In Part C, 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 Part D, 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 across multiple expansion cohorts involving eligible participants.

Study Type : INTERVENTIONAL
Estimated Enrollment : 365 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-03-23
Estimated Primary Completion Date : 2026-12-15
Estimated Study Completion Date : 2027-09-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

Location Details

NCT05669430

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

The Angeles Clinic and Research Institute

Los Angeles, California, United States, 90025

NOT YET RECRUITING

United States, Colorado

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

Denver, Colorado, United States, 80218

RECRUITING

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06511

NOT YET RECRUITING

United States, Florida

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida, United States, 33916

RECRUITING

United States, Indiana

Community Health Network, Inc.

Indianapolis, Indiana, United States, 46256

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Road cancer

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Detroit, Road cancer, United States, 48201

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

NOT YET RECRUITING

United States, Tennessee

Verdi Oncology Tennessee, Scri Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

Oncology Consultants, P.A.

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031