Study of Oral MRT-2359 in Selected Cancer Patients

Sponsor: Monte Rosa Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05546268

Provider View

This clinical trial is testing a new oral medication, MRT-2359, in patients with certain types of cancer that have already been treated. The study aims to find the safest and most effective dose of MRT-2359 and to see if it can help control these cancers.

Patient Parameters

Program Overview

This study is exploring a new treatment, MRT-2359, for patients with specific types of cancer, including certain lung cancers, high-grade neuroendocrine cancer, and diffuse large B-cell lymphoma (DLBCL). The trial is in two parts: Phase 1 focuses on finding the safest dose, while Phase 2 looks at how well the treatment works. Patients will receive increasing doses of MRT-2359 to determine the best dose for future studies. The study also includes patients with specific genetic markers or types of breast and prostate cancer.

Description

This clinical trial is testing a new oral drug called MRT-2359 in patients with certain cancers that have already been treated. The study is divided into two phases:

  • Phase 1: The main goal is to find out how safe MRT-2359 is, how well patients can tolerate it, and what the best dose is for future studies.
  • Phase 2: The focus is on seeing if MRT-2359 can help shrink or control tumors in patients with these cancers.

The study includes patients with specific types of cancer, such as non-small cell lung cancer, small cell lung cancer, high-grade neuroendocrine cancer, and diffuse large B-cell lymphoma. It also includes patients with tumors that have certain genetic changes, like L-MYC or N-MYC amplification, and some types of breast and prostate cancer. Participants will receive MRT-2359 in increasing doses to find the safest and most effective dose. The study will also look at how the drug affects the body and how the body processes the drug.

Eligibility Criteria

Inclusion Criteria

  • Have a specific type of advanced cancer or DLBCL for which no standard treatments are available.
  • Be 18 years or older and willing to give informed consent.
  • Have a life expectancy of at least 3 months and be in relatively good health (ECOG status 0-2).
  • Have measurable cancer that can be tracked using standard criteria.
  • Have good organ function based on lab tests.
  • Women of childbearing age must agree to use birth control during the study and for 90 days after the last dose.
  • Men must agree to use birth control during the study and for 90 days after the last dose.

Exclusion Criteria

  • Have received chemotherapy, radiation, or other cancer treatments within 21 days before starting the study, unless certain conditions are met.
  • Have taken bisphosphonates or denosumab within 14 days before starting the study, unless for acute hypercalcemia.
  • Cannot swallow pills.
  • Have had a bad reaction to a similar drug in the past.
  • Have had a stem cell transplant and not fully recovered.
  • Have had a stem cell transplant from a donor within the past 6 months or have symptoms of graft-versus-host disease.
  • Have received a live vaccine within 90 days before starting the study.
  • Have had a COVID-19 vaccine within 14 days before starting the study.
  • Are taking high doses of steroids.
  • Have a condition that affects how the body absorbs medication.
  • Have another active cancer unless it is controlled and not requiring treatment.
  • Have active cancer in the brain or spinal cord unless treated and stable.
  • Have a history of lung inflammation that required steroids.
  • Have HIV unless on treatment with undetectable levels.
  • Have hepatitis B or C unless treated with undetectable levels.
  • Have significant heart disease.
  • Are pregnant or breastfeeding.

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