First-in-Human Trial Assessing Novel Drug in Patients With Solid Tumors Launches

The primary objective of the early-stage trial is to determine the maximum tolerated dose of the novel drug in a group of patients with recurrent and/or refractory solid tumors.

The first patient has been treated with IMA401, an investigational T-cell engaging receptor, in a first-in-human, early-stage clinical trial to assess the maximum tolerated dose in a group of patients with recurrent and/or refractory solid tumors, according to the agent’s manufacturer, Immatics N.V.

“IMA401 is the first (T-cell engaging receptor) candidate from our TCR Bispecifics pipeline entering clinical development and expands our clinical portfolio with an exciting new TCR-based immunotherapy approach that can be supplied off-the-shelf (the production of large quantities of T cells originating from healthy donors and storing them until needed for transplant) compared to autologous cell therapies,” Cedrik Britten, chief medical officer at Immatics, said in a press release. “Our (T-cell engaging receptor) IMA401 could treat a range of solid tumors and therefore meet currently unmet needs of a broad patient population.”

The plan is to enroll approximately 50 patients with recurrent and/or refractory solid tumors to assess the safety and efficacy of treatment with IMA401.

Identifying the number of patients who experience side effects that lead to dose reductions will be the primary aim of the phase 1a/1b clinical trial. Additional objectives include, but are not limited to, evaluating the percentage of patients who experience a treatment-emergent side effect as well as the overall response rate (the percentage of patients whose disease completely or partially responds to study treatment) and progression-free survival (the percentage of patients who are alive without their disease getting worse following study treatment).

Enrolled patients must be aged 18 years or older, have confirmed and documented advanced and/or metastatic solid tumor, as well as a life expectancy of at least two months, among other criteria.

Patients will be excluded from the study for multiple reasons, including if they had received a prior autologous stem cell transplantation or organ transplantation.

This phase 1 trial, according to the press release, is being used to investigate the study drug in patients with tumors of high MAGEA4/8 prevalence, such as squamous non-small cell lung carcinoma, small cell lung cancer, head and neck squamous cell carcinoma, bladder, uterine, esophageal and ovarian carcinomas, as well as melanoma, sarcoma subtypes and other solid cancer types.

The initial phase of the trial is expected to be completed by November 2025 with the overall study expected to be completed by November 2027.

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