Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
Status:
Completed
Trial end date:
2021-07-26
Target enrollment:
Participant gender:
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
tumors.
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 tumor's objective response rate.
Radiological tumor 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.