Intensity Therapeutics has reported positive safety results from a Phase I/II IT-01 clinical trial evaluating INT230-6 for the treatment of patients with different types advanced solid tumour malignancies.
Results were announced following completion of the first safety cohort (A) of the IT-01 trial, which expects to enrol around 60 patients.
Study findings have revealed that no dose-limiting toxicities were reported after administering the INT230-6 intratumoral drug injections into superficial lesions in six patients with either ovarian, thyroid, head and neck or skin cancers.
Three drug-related, local, mild-to-moderate reversible adverse events were reported, while no drug-related series adverse events, as well as systemic and procedure-related events were observed so far in the trial.
Findings are similar to the observed low systemic exposure levels of the active agents comprising INT230-6.
After reviewing patient data, the study steering committee (SSC) decided to start treating patients with deep tumours, including in cohort B1, and to increase the frequency and dose for superficial tumours in cohort E.
As a result, the IT-01 trial has enrolled and dosed a sentinel patient’s deep tumour, a bile duct carcinoma in the liver.
Intensity Therapeutics chief medical officer Ian Walters said: “Our murine studies with INT230-6 have shown our drug’s ability to stimulate a strong adaptive immune response, in addition to the direct tumour killing effect.
“Those results also indicated a substantial benefit when our drug is given with an anti-PD-1 agent. Thus, as part of our clinical study, we have planned a cohort that combines our INT230-6 with checkpoint blockade compounds such as anti-PD-1 antibodies.”
The IT-01 trial is currently enrolling patients in the US and in Canada. It will also be conducted in various countries and includes a cohort combining INT230-6 with an anti-PD-1 antibody.
Primary endpoint of the trial is to evaluate the safety and tolerability of multiple intratumoral doses of INT230-6.
Secondary evaluations of the trial are to understand the preliminary efficacy of INT230-6 by measuring the injected and bystander tumour responses.