Study on GV20-0251 Alone and with Pembrolizumab for Treating Solid Tumor Cancers

Sponsor: GV20 Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05669430

Provider View

This clinical trial is testing a new drug, GV20-0251, both on its own and in combination with another drug, pembrolizumab, to see if it can help treat advanced solid tumors that have not responded to other treatments.

Patient Parameters

Program Overview

The study aims to find out if GV20-0251, a new treatment, is safe and effective for people with advanced solid tumors that have not improved with standard treatments. The trial will test GV20-0251 alone and in combination with pembrolizumab, a drug that helps the immune system fight cancer. Participants will be monitored to see how well the treatment works and if it causes any side effects.

Description

This study is divided into four parts:

  • Part A: Tests different doses of GV20-0251 to find the safest and most effective dose.
  • Part B: Further examines how well GV20-0251 works and its safety at the chosen dose.
  • Part C: Tests GV20-0251 combined with pembrolizumab to find the best dose for this combination.
  • Part D: Further examines the combination of GV20-0251 and pembrolizumab to see how well it works and its safety.

Participants will receive the study drugs and undergo various tests to monitor their health and the treatment's effects. The study will help determine if these treatments can effectively shrink tumors and improve patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced solid tumors that have worsened despite previous treatments.
  • Have tried standard treatments or are not eligible or have declined them.
  • Must have measurable tumors based on specific criteria.
  • If previously treated with a checkpoint inhibitor, there must be proof of disease progression.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of at least 12 weeks for Parts A and C, and 24 weeks for Parts B and D.
  • Willing to provide a tumor biopsy before and during treatment, if possible.
  • Free of other active cancers for at least 2 years.
  • Have lab test results within required limits.
  • Agree to use effective contraception if of childbearing potential.
  • Parts B, C, and D may include specific cancer types like endometrial carcinoma, head and neck carcinoma, melanoma, non-small cell lung cancer, and certain colon or rectum cancers.

Exclusion Criteria

  • Have acute leukemia or CLL (Parts A and B only).
  • Have heart disease or unstable heart rhythms.
  • Have active, uncontrolled infections.
  • Have active autoimmune diseases or need chronic steroid or immunosuppressive therapy.
  • Have had major organ or bone marrow transplants.
  • Have cancer in the brain or spinal cord causing symptoms.
  • Have serious non-cancerous diseases.
  • Are pregnant or breastfeeding.
  • Have recently received certain cancer treatments or surgeries.
  • Are currently in another clinical trial or have been in one recently.
  • Have liver metastases unless approved by the study sponsor.
  • Have had severe immune-related side effects from previous cancer treatments.
  • Have other progressing cancers needing treatment within the past 2 years.
  • Have severe allergies to pembrolizumab or its ingredients (Parts C and D only).
  • Have lung diseases requiring steroids (Parts C and D only).
  • Have conditions that could interfere with the study (Parts C and D only).
  • Have active substance abuse issues.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.