Indaptus Therapeutics doses first subject in ongoing Phase 1 lab

Indaptus Therapeutics announces the dosing of the first subject in 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. After Decoy20 dosing, the subject experienced expected and manageable adverse events believed to be related to the immune system activating components known to be in the product. A second subject in the first three-subject cohort is expected to be enrolled following final assessment of the safety and tolerability associated with dosing of the first subject, per the study protocol. 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 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.