IMA402 (bispecific T cell engaging receptor molecule)

Gynecological tumors / Breast cancer, Skin tumors, Thoracic tumors
Endometrial cancer, Melanoma, Non-small cell lung cancer (NSCLC)
other systemic therapies
IMA402-101 is a multicenter, open-label, Phase I dose-escalation study evaluating the bispecific T-cell receptor (TCER®) molecule IMA402 in patients with PRAME-positive solid tumors. The primary objective is to evaluate safety, tolerability, and to determine the recommended Phase II dose (RP2D) based on dose-limiting toxicities (DLTs). Eligible participants include adult patients with recurrent or refractory malignancies, including cutaneous and uveal melanoma as well as non-small cell lung cancer. Enrollment requires confirmation of the HLA-A*02:01 haplotype and documented PRAME expression within the tumor tissue. The investigational product is administered intravenously in ascending dose cohorts. Key secondary endpoints include pharmacokinetics and preliminary anti-tumor activity assessed by RECIST v1.1 criteria.
The IMA402 study is a first-in-human clinical trial evaluating a novel drug in various types of advanced cancer. The active agent, IMA402, is designed to specifically recognize a protein (PRAME) on cancer cells while simultaneously activating the body's own immune cells to attack the tumor. The primary goal of this early Phase I study is to evaluate the safety of the drug and determine a tolerable dosage. Eligible participants are adults with solid tumors, such as lung cancer or melanoma, for whom standard treatments are no longer effective. Before starting, laboratory tests confirm whether the patient's blood type and tumor possess the necessary biological characteristics for this therapy. Participants receive the drug as an intravenous infusion and are closely monitored by medical staff. To evaluate the initial anti-tumor activity of IMA402 (Phase I) To evaluate anti-tumor activity of IMA402 (Phase II) To describe the PK of IMA402 (Phase I/II)