Indaptus Therapeutics activates Emory Winship Cancer Institute as trial site

Indaptus Therapeutics announces that Atlanta, Ga.-based Emory Winship Cancer Institute has become a new clinical trial site for INDP-D101. INDP-D101 is the Company’s 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. Emory has begun screening patients. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose and recommended phase 2 dose, as well as to assess Decoy20 pharmacokinetics, pharmacodynamics and clinical activity. The Phase 1 study was initiated with a single dose escalation, which is planned to be followed by an expansion with continuous weekly administration of Decoy20. The study is enrolling patients with advanced/metastatic solid tumors, who have exhausted approved treatment options. The primary endpoint of the study is incidence, relatedness and severity of adverse events and treatment-emergent adverse events and determination of the number of subjects per cohort with dose limiting toxicity-based adverse events. Secondary endpoints include the incidence of anti-drug antibodies and neutralizing antibodies pre- and post-treatment, change in Decoy20 PK parameters over time, objective response rate in subjects with measurable disease and duration of response.