Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, announces it has signed an agreement to commence a new Phase I trial, called INSIGHT-003, to evaluate the combination of lead product candidate eftilagimod alpha (“efti” or “IMP321”) in conjunction with an existing approved standard of care therapy consisting of a chemotherapy agent and an anti-PD-1 therapy.
INSIGHT-003 will be an investigator-initiated trial conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. The trial will be run as an amendment to the protocol of the ongoing INSIGHT trial as the third arm (Stratum C) with Prof. Dr. Salah-Eddin Al-Batran as lead investigator.
Up to 20 patients with various solid tumours will be recruited to participate in the trial. Patients will receive 30 mg doses of efti every two weeks for 24 weeks in conjunction with standard of care chemotherapy plus anti-PD-1 therapy. Thereafter, patients will enter a maintenance phase and receive either efti alone or in double or continued triple combination with anti-PD-1 therapy. The trial will assess the safety, tolerability and initial efficacy of the combination.
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