J15195 - A phase I-Ib/II, open-label, multi-center study of the safety and efficacy of MBG453 as single agent and in combination with PDR001 in adult patients with advanced malignancies
Johns Hopkins Kimmel Cancer Center in Baltimore
Phase 1/1b: During phase I/Ib there will be a dose escalation to determine the dose of MBG453 (a Tim3 inhibitor) alone or in combination with PDR001 (anti PD-1) and phase II: to assess efficacy and indication in high expression of TIM-3 & PD-L1, compare to current data and initial safety, PK and efficacy of q 2 week vs q 4 week dosing in advanced malignancies; melanoma, non-small cell lung cancer & renal cell carcinoma.
Subjects greater than 18 yrs old, phase I-Ib will include subjects with melanoma, NSCLC & RCC who progressed or were intolerant or for who a standard treatment exist and have not received an anti PD-1 or anti PD L1. Phase 1 will be treated with escalating doses of MBG453 alone. Phase 1b will receive combination MBG453 with PDR001.
Phase 1 will enroll 2 cohorts of MBG453 alone prior to enrollment in phase 1 b MBG453 and PDR001 combination. Patients will have histologically confirmed advanced or metastaic solid tumors. Phase 1-1b will initially enroll PD1/PDL1 naïve patients that have progressed following standard therapy or intolerant to standard therapy or for who there is no standard therapy. Part II ; MBG453 in combination with PDR001 is for Melanoma, NSCLC or RCC who progressed following standard therapy, intolerant to standard therapy and can have received prior anti PD1 or anti PDL1 treatment. May not have received anti CTLA4 antibodies. Must have biopsiable tumor. Patients with history of autoimmune disease are excluded.
12/09/2019 05:03 AM