Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
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. Please note: Arm A has now closed.
Conditions
This trial is treating people with renal cell carcinoma (a type of kidney cancer)
Eligibility
Inclusion
- Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent.
- Men and women 18 years of age or older.
- Histologically confirmed advanced or metastatic hepatocellular carcinoma that progressed while receiving at least one previous line of systemic therapy, including sorafenib, or who are intolerant of or refused sorafenib treatment following progression on standard therapy including surgical and/or local regional therapies, or standard therapy considered ineffective, intolerable, or inappropriate or for which no effective standard therapy is available.
- Histologically confirmed advanced or metastatic renal cell carcinoma with clear cell component who received one or two prior lines of antiangiogenic therapy in addition to no more than three previous regimens of systemic therapy including cytokines and cytotoxic chemotherapy agents.
- Disease according to irRECIST that can be reliably and consistently followed.
- Documented disease progression during or after the last treatment regimen and within 6 months before study enrollment.
- Tumor amenable to tumor biopsy and subject agreeable to tumor biopsy at study entry and during therapy with study treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Acceptable organ function.
Exclusion
- History of severe hypersensitivity to mAbs, excipients of the APL-501, nivolumab, or APL-101.
- History of receiving treatment with any c-Met signaling pathway inhibitor (marketed or investigational agents).
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-stimulation pathways).
- Unwilling to swallow orally administered medication whole.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn's, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- Documented and/or known history of human immunodeficiency virus (HIV) for HCC and RCC subjects, or historical seropositive results consistent with active infection for hepatitis C virus (HCV) or hepatitis B virus (HBV) (RCC only).
- HCC subjects receiving active antiviral therapy for HCV.
- Active co-infection with HBV and HCV.
- Active co-infection with HBV and hepatitis D virus.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
CBT Pharmaceuticals (Australia) Pty Ltd.
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
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