The first patient has successfully received treatment in a Phase 1/2 trial evaluating Intensity Therapeutics‘ drug candidate INT230-6 in different types of advanced solid tumors.
The study will enroll up to 60 patients, and is currently recruiting in the U.S. at two hospitals associated with the University of Southern California (USC) and in Canada at the University Health Network (UHN) in Toronto.
The study began after Intensity’s investigational new drug (IND) application was accepted by the U.S. Food and Drug Administration, and Health Canada issued a No Objection Letter after submission of a clinical trial application (CTA).
“Bringing our novel product, INT230-6, into human testing is a major milestone for Intensity Therapeutics,” Lewis H. Bender, president and CEO of Intensity Therapeutics, said in a press release. “Over the past few years our company has demonstrated impressive tumor shrinkage in several murine models of cancers. INT230-6 eradicated large tumors, activated a systemic immune response and improved survival.”
“Animals having a complete response acquired the capability to spontaneous clear re-challenges of the same cancer throughout the remainder of their lives, suggesting a protective effect similar to that of a vaccine,” Bender added.
INT230-6 is an anti-cancer treatment containing potent drugs that disperse throughout tumors and enter tumor cells. It is composed of three agents at a fixed ratio: an agent that increases cell permeability, and two chemotherapy drugs, cisplatin and vinblastine. The accumulation of these drugs inside cancer cells leads to cancer cell death and elicits strong adaptive immune responses against the mutated cells.
The IT-01 Phase 1/2 trial (NCT03058289) is a multi-cohort study designed to assess the safety and effectiveness of multiple intratumoral doses of INT230-6.
The study will first assess the safety of INT230-6 in tumors treated near the surface of the skin, like breast cancer, melanoma, head and neck cancer, and lymphomas. Subsequent cohorts will include patients with deep tumors, including liver, pancreatic, colon, lung, and other cancers.
Preclinical animal studies showed a strong synergy of INT230-6 with immune modulator drugs. An additional cohort will also test the safety and efficacy of INT230-6 in combination with anti-PD-1 agents.
The study’s primary objective is to assess the safety and tolerability of INT230-6, and secondary measures include preliminary efficacy, determined by a reduction in tumor volume, and the drug’s behavior in patients’ blood and tumors.
Other exploratory measures include regression of non-injected tumors, overall response rate, progression-free survival, and overall survival.