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NC410 plus Keytruda will be studied in a phase 1b/2 trial for patients with certain solid cancers that either did not respond to or have not been treated with an immunotherapy agent.
A recently launched clinical trial will evaluate a new drug, NC410, in combination with the immunotherapy agent Keytruda (pembrolizumab) for patients with solid tumors that either did not respond to or never was treated with an immunotherapy agent, according to NextCure, the manufacturer of NC410.
The phase 1b/2 trial marks the first time NC410 is being studied in humans. Researchers plan to enroll patients with colorectal, esophageal, endometrial or head and neck cancers that is refractory (non-responsive) to immunotherapy treatment or patients with microsatellite stable or microsatellite instability-low colorectal or ovarian cancer that has not previously been treated with immunotherapy. The plan is to enroll approximately 100 patients.
NC410 works by blocking LAIR-1, a receptor found on T cells and myeloid cells that suppresses the immune system. The drug will be given alongside Keytruda, a checkpoint blockade which inhibits the protein that helps the cancer hide from the immune system. In doing so, the immune system can then find and attack the cancer.
According to NextCure, elevated collagen levels around the cancer cells — an area called the extracellular matrix — can result in immunotherapy being ineffective.
“In non-clinical colorectal models and early-stage monotherapy clinical studies, we have demonstrated that NC410 can remodel collagen in the (extracellular matrix), which enhances T cell infiltration into the tumor,” Michael Richman, the president and CEO of NextCure, said in a company-issued press release.
Findings from the phase 1b portion of the study, which will determine the maximum tolerated dose of the drug, are expected to be reported in the middle of 2023. Then, the phase 2 portion of the trial, which will analyze how well the drug combination shrinks cancer, will begin.
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