Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumours

Official Title

Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies

Summary:

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumours. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumour's objective response rate. Radiological tumour assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.

Trial Description

Primary Outcome:

  • Maximum tolerated dose (MTD) of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine in patients with mesothelin-expressing cholangiocarcinoma and pancreatic adenocarcinoma
  • Objective response (qualitative improvement from baseline) of anetumab ravtansine for monotherapy and combination therapy in mesothelin expressing advanced solid tumours
  • Durable disease control (lack of progression from baseline) of anetumab ravtansine in indications pancreatic and gastric cancer (co-primary endpoint)
Secondary Outcome:
  • Number of serious and non-serious adverse events (AEs)
  • Disease control rate (DCR)
  • Duration of response (DOR)
  • Durable response rate (DRR)
  • Progression free survival (PFS)
  • Durable disease control rate (DDCR) of anetumab ravtansine in indications other than pancreatic and gastric cancer

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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