Indaptus Therapeutics has chosen the Emory Winship Cancer Institute in Atlanta, Georgia as a new clinical trial site for its ongoing Phase I INDP-D101 clinical trial of Decoy20 in advanced/metastatic solid tumours patients.
The open-label, multicentre, first-in-human, dose escalation, and expansion trial has been designed for evaluating the tolerability, safety, pharmacokinetics (PK), pharmacodynamics, and clinical activity of Decoy20.
It will also determine the maximum tolerated dose (MTD), as well as the recommended Phase II dose (RP2D).
The company stated that the Emory Winship Cancer Institute commenced screening participants for the trial.
It noted that the Phase I trial began with a single dose escalation and will be followed by an expansion with the continuous weekly administration of Decoy20.
Advanced/metastatic solid tumours patients, who have exhausted approved treatment options, are being enrolled in the trial.
Indaptus Therapeutics CEO Jeffrey Meckler said: “Emory joining the INDP-D101 trial is both validation of the scientific concepts behind Decoy20 in early testing, as well as acknowledgement of the remaining unmet medical need, and the need for additional hope for patients with advanced solid tumours.
“We hope to continue the pace at which we are activating trial sites in order to more rapidly advance the trial toward initial data points which, in turn, will continue to facilitate the development of what we believe is a potentially important innovation in the treatment of solid tumours.”
Incidence, adverse events relatedness and severity, treatment-emergent adverse events, and the number of participants per cohort with dose limiting toxicity-based adverse events are the trial’s primary endpoints.
Change in Decoy20 PK parameters over time, the incidence of anti-drug antibodies and neutralising antibodies pre- and post-treatment, objective response rate in measurable disease patients, and duration of response will be some of the trial’s secondary endpoints.