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  • CBT-APOLLO

    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

    Summary of trial and patient characteristics

    Cancer Type Kidney, Liver
    Trial Type Treatment
    Phase Phase I, Phase II Tumour Stream Heptocellular carcinoma; renal cell carcinoma
    Age Range 18 years and older Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2018-09-05
    Molecular Target Anticipated End Date 2020-12-15
    Cancer Type Kidney, Liver
    Trial Type Treatment
    Phase Phase I, Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Heptocellular carcinoma; renal cell carcinoma
    Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Anticipated Start Date 2018-09-05
    Anticipated End Date 2020-12-15

    Trial 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.

    Lay Summary

    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

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Sue Yeend syeend@adelaidecancercentre.com.au 08 8292 2240 Recruiting