Clinical Trial to Assess Experimental Drug as Single-Agent, and Combined With Keytruda Across Several Solid Tumors Launches

The aim of the early-stage trial is to identify the safety of the experimental drug as either a single-agent therapy as well as in combination with Keytruda in adults with multiple solid tumors.

NGM Biopharmaceuticals has launched an early-stage clinical trial to investigate the safety and preliminary efficacy of NGM438, an experimental drug, alone or in combination with Keytruda (pembrolizumab) in a group of adults with various solid tumors.

The multicenter trial will enroll up to approximately 80 adults, according to a company-issued press release. The plan is to enroll patients with multiple tumor types, including, but not limited to, kidney cancer, melanoma, breast cancer, mesothelioma and non-small cell lung cancer.

The first two parts of the phase 1 trial will consist of the investigators identifying the appropriate dosing of single-agent NGM438 as well as the combination of NGM438 and Keytruda.

Once those portions of the trial have been completed, the plan is to then enroll patients to receive NGM438 by itself for one cycle of treatment. Then, patients would go on to receive the combination therapy.

Enrolled patients must have disease that progressed or did not respond to all available therapies known to induce a benefit for their tumor type. Additionally, patients must have adequate bone marrow, kidney and liver function to be enrolled onto the trial.

The trial is expected to be completed by summer 2024.

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