APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
Status:
Active, not recruiting
Trial end date:
2021-12-15
Target enrollment:
Participant gender:
Summary
Study Design and Investigational Plan:
This is an open-label Phase 1/2 study to assess the safety and tolerability of combination
PD-1 inhibitor (APL-501 or nivolumab) administered concomitantly with c-Met inhibitor
(APL-101), to determine the recommended Phase 2 dose of the combination, and to obtain
preliminary efficacy in HCC or RCC subjects with advanced or metastatic disease that have not
been previously treated with a PD 1 inhibitor or a c-Met inhibitor. HCC subjects will receive
the combination APL-501 plus APL-101 while RCC subjects will receive the combination
nivolumab plus APL-101. In Phase 1, mandatory archival or fresh tumor biopsies will be
collected. In Phase 2, a mandatory fresh tumor biopsy will be required for study entry and
another fresh biopsy will be collected between Cycles 2 and 4. The frequency of
administration of PD-1 inhibitors will be every 2 weeks starting in Cycle 1 on Day 8 and Day
22 of a 35-day cycle with all subsequent cycles on Day 1 and Day 15 of 28-day cycles. APL-101
will be administered orally every 12 hours continuously on an empty stomach.