Indaptus Therapeutics initiates first-in-human Phase 1 trial of Decoy20

Indaptus Therapeutics 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 and recommended phase 2 dose, as well as to assess Decoy20 pharmacokinetics, pharmacodynamics and clinical activity. 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. 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 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.