APOLLO-1 : A Phase 1/2 Dose Escalation and Expansion Study of Combination CBT-501 or Nivolumab With CBT-101 in Locally Advanced or Metastatic Hepatocellular and Renal Cell Carcinoma

Trial Identifiers

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• NCT03655613

Scientific Title

A Phase 1/2 Dose Escalation and Expansion Study of Combination CBT-501 or Nivolumab With CBT-101 in Locally Advanced or Metastatic Hepatocellular and Renal Cell Carcinoma

Commercial Sponsor

CBT Pharmaceuticals (Australia) Pty Ltd.

Summary

This is a dose escalation and expansion trial, in which patients will be assigned to either Arm A or Arm B based on their cancer type. In Arm A, hepatocellular cancer patients will receive an intravenous dose (3mg/kg) of CBT-501 every two weeks and an oral dose (300 or 400mg) of CBT-101 twice daily continuously until documented disease progression, study discontinuation or withdrawal. In Arm B, renal cell carcinoma patients will receive an intravenous dose (3mg/kg or 240mg) of nivolumab every two weeks and an oral dose (300 or 400mg) of CBT-101 twice daily continuously until documented disease progression, study discontinuation or withdrawal.