RECRUITING

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

Conditions

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 GV20-0251

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-03-23

Study Completion:2027-09-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05669430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Study Contact

GV20 Therapeutics

CONTACT

617-256-2846

clinicaltrials@gv20tx.com

Study Locations (Sites)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

United States

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

Denver, Colorado, 80218

United States

Yale University

New Haven, Connecticut, 06511

United States

Florida Cancer Specialists & Research Institute, LLC

Fort Myers, Florida, 33916

United States

Community Health Network, Inc.

Indianapolis, Indiana, 46256

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center

Detroit, Michigan, 48201

United States

NYU Langone Health

New York, New York, 10016

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Verdi Oncology Tennessee, Scri Oncology Partners

Nashville, Tennessee, 37203

United States

Oncology Consultants, P.A.

Houston, Texas, 77030

United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

Virginia Cancer Specialists

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: GV20 Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-23

Study Completion Date2027-09-05

Study Record Updates

Study Start Date2023-03-23

Study Completion Date2027-09-05

Terms related to this study

Keywords Provided by Researchers

GV20-0251

Additional Relevant MeSH Terms

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