GV20-0251 in Patients With Solid Tumor Malignancies

INTRODUCTION

Org Study ID: GV20-0251-100
Secondary ID: N/A
NCT ID: NCT05669430
Sponsor: GV20 Therapeutics

This is a Phase 1 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.

This is a Phase 1 non-randomized, open label, multi-center study to be conducted in two parts (Parts A and B).

Part A involves a 3 + 3 dose escalation scheme to evaluate safety and dose limiting toxicities and to establish the maximum tolerated dose and/or the recommended Phase 2 dose of GV20-0251.

Part B consists of multiple expansion cohorts in which eligible participants will be treated at the recommended Phase 2 dose of GV20-0251 to further characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of GV20-0251 as well as to evaluate anti-tumor activity in patients with selected malignancies.

The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit, Safety Follow-Up Period and a Survival Follow-Up Period.

Overall Status
Recruiting
Start Date
March 23, 2023
Phase
Phase 1
Study Type
Interventional

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

Solid Tumor
Adult
Refractory Cancer
Bladder Urothelial Carcinoma
Cholangiocarcinoma
Adenocarcinoma of the Colon
Endometrial Carcinoma
Head and Neck Carcinoma
Cutaneous Melanoma
Non-small Cell Lung Cancer
Adenocarcinoma of the Rectum

Inclusion Criteria:
* >= 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

- * One or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1

- * 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

- * 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

- * Part B ONLY must include the following tumor types:
* Cohort B1: bladder urothelial carcinoma

- * Cohort B2: cholangiocarcinoma

- * Cohort B3: proficient MMR (pMMR)/MSS adenocarcinoma of the colon or rectum

- * Cohort B4: proficient MMR (pMMR)/MSS endometrial carcinoma

- * Cohort B5: deficient MMR (dMMR)/MSI-H endometrial carcinoma

- * Cohort B6: squamous head and neck carcinoma

- * Cohort B7: cutaneous melanoma

- * Cohort B8: non-small cell lung cancer
Exclusion Criteria:
* Participant with acute luekemia or CLL

- * 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

- * Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection

- * 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

- * Active substance abuse

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Name: N/A

Role: N/A

Affiliation: N/A

Name: GV20 Therapeutics

Phone: 617-256-2846

Email: clinicaltrials@gv20tx.com

Facility	Status	Contact
Facility: The Angeles Clinic and Research Institute Los Angeles, California 90025 United States	Status: Recruiting	Contact: Contact GV20 Therapeutics clinicaltrials@gv20tx.com Principal Investigator Kristopher Wentzel, MD
Facility: Yale University New Haven, Connecticut 06511 United States	Status: Recruiting	Contact: Contact GV20 Therapeutics clinicaltrials@gv20tx.com Principal Investigator Patricia LoRusso, DO
Facility: NYU Langone Health New York, New York 10016 United States	Status: Recruiting	Contact: Contact GV20 Therapeutics clinicaltrials@gv20tx.com Principal Investigator Janice Mehnert, MD
Facility: Oregon Health & Science University Portland, Oregon 97239 United States	Status: Recruiting	Contact: Contact GV20 Therapeutics clinicaltrials@gv20tx.com Principal Investigator Shivaani Kummar, MD
Facility: Oncology Consultants, P.A. Houston, Texas 77030 United States	Status: Recruiting	Contact: Contact GV20 Therapeutics clinicaltrials@gv20tx.com Principal Investigator Jose Peguero, MD
Facility: Virginia Cancer Specialists Fairfax, Virginia 22031 United States	Status: Recruiting	Contact: Contact GV20 Therapeutics clinicaltrials@gv20tx.com Principal Investigator Alexander Spira, MD

Brief Title: GV20-0251 in Patients With Solid Tumor Malignancies

An Open-Label Study of GV20-0251 in Patients With Advanced and/or Refractory Solid Tumor Malignancies

INTRODUCTION

BRIEF SUMMARY

DETAILED DESCRIPTION

PRIMARY OUTCOMES

CONDITION

ELIGIBILITY

OFFICIAL INFORMATION

Overall Contact

LOCATION

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