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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Stomach and upper gastrointestinal tract,Urinary systemKidney,Liver,Renal cell carcinoma

Trial Overview Read MoreRead more

This phase I/II trial is evaluating the combination of an oral drug (CBT-101) with two immunotherapy drugs (CBT-501 or Nivolumab) in patients with locally advanced or metastatic hepatocellular cancer (liver cancer) or renal cell carcinoma (a type of kidney cancer).
 

This trial is treating patients with hepatocellular cancer (liver cancer) or renal cell carcinoma (a type of kidney cancer).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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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.

Recruiting Hospitals Read MoreRead more

Royal Melbourne Hospital, Colorectal Medicine / Gastroenterology
Parkville
Ms Virginia Bird
virginia.bird@mh.org.au
03 9342 7798

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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