A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects with Advanced Refractory Cancers (Protocol IT-01)
Johns Hopkins Kimmel Cancer Center in Baltimore
Assess the safety and tolerability of multiple intratumoral doses of INT230-6 in subjects with advanced or recurrent malignancies
Men and Women greater than 18 years of ageGood physical performance status as determined by study teamIncludes subjects with loco-regional disease that have relapsed/recurred within 6 months of chemo-radiation and who have no standard of careRequires metastatic disease with either superficial or deep tumors that are measurable amendable to tumor injection as determined by study team radiologist.Prior therapy must have been completed at least 4 weeks prior to enrollment Adequate lab values as determined by study team and parameters.
This is a clinical study of a new investigational treatment that uses a novel drug product called “INT230-6" to treat advanced cancers.Subjects will receive injections monthly for up to 5 doses of INT230-6. An optional cohort may be developed later for injections that will be given every 2 weeks for up to 5 doses. The protocol allows for retreatment in responding subjects who appear to relapse less than 1 year after demonstrating an objective response.Required study visits include day of injection, first day post treatment follow up, and then weekly for first two weeks post treatment in cycle 1. Cycles 2-5 require visits the day of inject and weekly for first two weeks post treatment. Once all 5 injections are completed, patient will have clinic follow up every 8 weeks, until progression or start of other therapy.Other follow up may be required as needed.
01/17/2020 05:03 AM