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Indaptus Therapeutics Announces Initiation of First-In-Human, Open Label, Dose Escalation and Expansion Multicenter Phase 1 Clinical Trial of Decoy20 in Patients with Advanced Solid Tumors
NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on
About this update from Indaptus Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP, “Indaptus” or “the Company”), a biotechnology company focused on discovering and developing transformative therapeutics for patients, today announces the initiation of INDP-D101, its first-in-human, open label, dose escalation and expansion, multicenter Phase 1 clinical trial of its lead compound Decoy20 in patients with advanced/metastatic solid tumors. The USC Norris Cancer Center in Los Angeles, California is the first activated clinical trial site that has been opened for patient enrollment, and patient screening is expected soon. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity. “The initiation of the dose-escalation part of our first-in-human Phase 1 trial of Decoy20 marks an important milestone in our early efforts to identify and study novel drugs for patients with solid tumors who have exhausted known life-prolonging treatment options and are thus facing poor prognosis. Based on the substantial preclinical data demonstrating safety and activity of Decoy20 alone and in combination with other oncology drugs, we are encouraged by the potential Decoy20 holds for those patients. In addition, evaluating Decoy20 in patients with advanced and metastatic solid tumors is an important initial step in our efforts to understand the potential of this investigational medicine to treat a broad range of cancers. We look forward to advancing to the expansion portion of the trial once the appropriate dose is identified,” said Boyan Litchev, M.D., Chief Medical Officer, Indaptus. The Phase 1 study will begin with a single dose escalation part followed by an expansion part with continuous administration of Decoy20. The study will enroll patients with advanced/metastatic solid tumors, who have exhausted the other known treatment options. More information can be found at www.clinicaltrials.gov. Primary endpoint of the study is incidence, relatedness and severity of adverse events and treatment-emergent adverse events and determining the number of subjects per cohort with dose limiting toxicity-based adverse events. Secondary endpoints include the incidence of...