Indaptus Therapeutics is set to commence the Phase I clinical trial of its Decoy20 in patients with advanced solid tumours that are unresponsive to presently approved treatments.
Decoy20 is claimed to possess the potential for treating a broad range of solid tumours including hepatocellular, colorectal and pancreatic carcinomas.
The development comes after the US Food and Drug Administration (FDA) granted clearance to the company’s Investigational New Drug (IND) application for the trial.
The company intends to launch the open-label dose escalation and expansion trial in the second half of this year.
It will analyse the safety, tolerability and initial efficacy of Decoy 20 in advanced solid tumour patients.
The trial will have a 3+3 design of dose-escalation cohorts.
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The trial protocol permits for analysis of additional dosing regimens, including continuous weekly dosing on establishing the preliminary safety of the therapy.
Indaptus CEO Jeffrey Meckler said: “We are excited to begin our first in human study of Decoy20, as there is still a significant unmet medical need for patients with advanced solid tumours.
“This is an important milestone for Indaptus, which brings us one step closer to our goal of demonstrating the utility of a multi-targeted and antigen-agnostic, systemic immunotherapy that primes and activates both innate and adaptive anti-tumour immune responses.”
Tumours are said to remodel and hinder systemic immune responses.
The Decoy technology of Indaptus showed the capability to mobilise innate and adaptive anti-tumour immune pathways with systemic dosing in pre-clinical tumour models.
Furthermore, in pre-clinical toxicology studies, it did not elicit sustained hallmarks of cytokine release syndromes.