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Trial Summary

CBT-501 or Nivolumab in Combination With CBT-101 in Locally Advanced or Metastatic HCC and RCC

Acronym:

CBT-APOLLO

ACTRN/NCT /ethics:

NCT03655613

Scientific title:

CBT-501 or Nivolumab in Combination With CBT-101 in Locally Advanced or Metastatic HCC and RCC

Sponsor / Cooperative group

CBT Pharmaceuticals (Australia) Pty Ltd

Summary:

This is an open-label Phase 1/2 study to assess the safety and tolerability of combination PD-1 inhibitor (CBT-501 or nivolumab) administered concomitantly with c-Met inhibitor (CBT-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 CBT-501 plus CBT-101 while RCC subjects will receive the combination nivolumab plus CBT-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. CBT 101 will be administered orally every 12 hours continuously on an empty stomach.

Trial & Patient Characteristics

Cancer TypeLiver, Kidney
Trial TypeTreatment
PhasePhase 1, Phase II
Age Range18+ years
SexBoth
Tumour StreamLiver, Kidney
Cancer StageMetastatic or Widespread, Locally Recurrent or Locally Advanced
Anticipated Start Date2018-09-05
Anticipated End Date2020-12-15

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal Investigator-
Recruitment StatusRecruitment on Hold