Our ongoing study evaluates the intratumoral administration of escalating doses of our new drug, INT230-6. We are treating patients with several types of refractory superficial and deep cancers including melanoma, head and neck, lymphoma, breast, pancreatic, colon, liver, lung. There are up to 9 cohorts of subjects in the escalation portion of the protocol. The first is a superficial tumor cohort with a low tumor load (1:4 ratio of drug to tumor). The 2nd,3rd and 4th cohorts are in superficial and deep tumors that escalates the total dose and maximal dose per any one tumor. Cohort 5/6/7 will explore a higher drug load (1:2 ratio) and will escalate the total dose and maximal dose per any one tumor. The 8th cohort is reserved for combination of INT230-6s with anti-PD1 agent, a well-known check point inhibitor. The 9th optional cohort will be added if a more frequent schedule would be deemed beneficial.
The primary study objective is to assess the safety and tolerability of single and multiple intratumoral doses of INT230-6 in subjects with advanced or recurrent malignancies. This will be assessed by the rate of ≥ grade 3 AE’s attributed to INT230-6 and not the underlying disease. All recorded adverse events will be listed and tabulated by system organ class, preferred term, and dose and coded according to the most current version of MedDRA. The incidence of adverse events will be tabulated and reviewed for potential significance and clinical importance. Adverse Events will be summarized for all reported data and by study period: a) up to and including 28 days post last dose of initial treatment, and b) from first dose of re-initiation of treatment, for subjects who re-initiate study therapy while in follow-up, up to 28 days post-dose of the last re-treatment dose. There are a number of secondary outcome measures. The first is a determination of preliminary efficacy. This will be measured by control or regression of injected tumors by measurement of length, width and height (in centimeters) radio-graphically.
We also intend to determine pharmacokinetic parameters of each of the 3 main components of INT230-6 after single and then multiple IT tumor site injections. The study is also collecting blood, genetic and tissue to identify biomarkers and evaluate immune activity.