Study on VMD-102 for Liver Cancer and Other Solid Tumors

Sponsor: VM Discovery, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07636785

Provider View

This clinical trial is testing a new drug, VMD-102, to see if it is safe and effective for treating advanced liver cancer and other solid tumors. The study will determine the best dose and evaluate how well the drug works against tumors.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new drug called VMD-102 in patients with advanced liver cancer and other solid tumors, such as uveal melanoma, kidney cancer, lung cancer, and colorectal cancer. The study will be conducted in two phases. Phase 1 will focus on finding the safest dose of VMD-102, while Phase 2 will assess how well the drug works in shrinking tumors. Researchers will also study how the drug moves through the body and identify any potential markers that could predict its effectiveness.

Description

This study is divided into two phases:

Phase 1:

  • The first phase will involve about 25 participants and will test different doses of VMD-102 to find the safest and most effective dose. Participants will receive the drug in 21-day cycles, and researchers will monitor for any side effects and how the drug is processed in the body. The goal is to determine the maximum tolerated dose and the recommended dose for Phase 2.

Phase 2:

  • In the second phase, the study will expand to include more participants to further evaluate the drug's effectiveness in shrinking tumors. Participants will be divided into two groups: one with liver cancer and another with other types of solid tumors. Researchers will continue to monitor safety and effectiveness, and may use biomarkers to guide enrollment.

Participants will need to provide tumor tissue samples for analysis, and women of childbearing potential must use effective contraception during the study. Men must also use condoms to prevent pregnancy during and after the study. Participants must have a life expectancy of at least three months and be able to swallow tablets.

Eligibility Criteria

Inclusion Criteria

  • Have advanced liver cancer or other solid tumors that cannot be removed by surgery or have spread to other parts of the body.
  • Have tried standard treatments without success or cannot tolerate them.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Have adequate organ function, including specific blood counts and liver and kidney function.
  • Women must not be pregnant and must agree to use effective contraception during and after the study.
  • Men must agree to use condoms and refrain from sperm donation during and after the study.
  • Have a life expectancy of at least three months.
  • Be able to swallow tablets.
  • Have completed any previous cancer treatments at least four weeks before starting the study drug.

Exclusion Criteria

  • Have received cancer treatment within the past two weeks.
  • Are pregnant, nursing, or planning to become pregnant during the study.
  • Have certain heart conditions or uncontrolled medical issues that could interfere with the study.
  • Have psychological or social conditions that could affect participation.
  • Have difficulty swallowing or absorbing oral medications.
  • Have active infections or other serious health conditions.
  • Have a history of organ transplantation requiring immunosuppressive therapy.
  • Have active hepatitis B or C infections.
  • Have uncontrolled HIV infection.
  • Are taking certain medications that cannot be stopped before the study.
  • Have any other condition that could increase risk or interfere with the study.

Locations

FACILITYZIPCITYSTATE
HonorHealth Research Institute85258ScottsdaleArizona

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