Clinical Trial Kicks Off Evaluating a New Drug for a Group of Solid Cancers

The first patient has been treated in a phase 1/2 clinical trial analyzing the novel drug MRT-2359 in patients with solid tumors that are driven by high MYC expression, according to Monte Rosa Therapeutics, the manufacturer of the treatment.

The goal of this phase 1/2 clinical trial is to assess the safety, efficacy and tolerability of treatment with the novel drug MRT-2359 for a group of patients with solid cancers, including lung cancer.

The goal of the clinical trial is to determine the safety, tolerability, how the drug moves through the body, how the drug acts within the body and preliminary clinical activity of MRT-2359.

The ideal dose of MRT-2359 will be determined in the first part of the study and then that will be used for phase 2.

Researchers plan on enrolling approximately 133 participants across eight cancer centers in the U.S. To be eligible, patients must have MYC-driven non-small cell lung cancer; small cell lung cancer; high-grade neuroendocrine cancer of any primary site; diffuse large B-cell lymphoma; and solid tumors with L-MYC or N-MYC amplification. Patients must have a life expectancy of three months or longer and have adequate organ function.

MRT-2359 is an oral drug that works by disrupting the process by which cells make proteins (translation), which leads to cancer proliferation and growth. Preclinical studies of the drug showed that the drug has anti-tumor activity in MYC-driven cancer cells.

“MYC transcription factors are well-defined drivers of human cancers and disrupting protein translation has emerged as a promising path to address this highly prevalent disease pathway,” said Dr. Filip Janku, chief medical officer of Monte Rosa, in a company-issued press release.

The researchers plan on completing the study in November 2027.

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