Study on mRNA-4359 Alone and with Immune Checkpoint Blockade for Advanced Solid Tumors

Sponsor: ModernaTX, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05533697

This clinical trial is testing the safety and tolerability of a new drug, mRNA-4359, both on its own and in combination with another drug, pembrolizumab, in patients with advanced solid tumors.

Patient Parameters

Program Overview

The main aim of this study is to see if the new drug mRNA-4359 is safe and well-tolerated when given alone or with pembrolizumab, a drug that helps the immune system fight cancer. The study involves patients with advanced solid tumors, such as melanoma, lung cancer, bladder cancer, and others, who have already tried standard treatments without success.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic cancer, such as melanoma, lung cancer, bladder cancer, or others, that can be measured by scans.
  • Have tried at least one standard treatment for advanced cancer, but it didn't work or you couldn't tolerate it.
  • Have a tumor that can be biopsied and another that can be monitored for response.
  • For certain lung cancer patients, have tried or been offered targeted therapies if you have specific genetic mutations.
  • Be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood and organ function based on specific tests.

Exclusion Criteria

  • Have active tumors or cancer spread in the brain or central nervous system.
  • Have received other cancer treatments or investigational drugs recently.
  • Need additional immune-suppressing medications or have unresolved side effects from previous treatments.
  • Plan to receive or have recently received a live vaccine.
  • Have unresolved side effects from previous cancer treatments, except for hair loss or skin changes.
  • Are pregnant, breastfeeding, or able to become pregnant and not using effective birth control.
  • Are sexually active and not using condoms or planning to donate sperm during and after the study.
  • Have any serious or unstable medical conditions that could affect your safety or ability to participate in the study.
  • Are enrolled in another clinical study, unless it's observational and non-interventional.

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