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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

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.
Breast, Endocrine, Esophageal, Gastrointestinal, Lung, Non Small Cell, Pancreatic
Phase I
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
Anetumab Ravtansine (BAY 94-9343), Cisplatin, Gemcitabine
Horn, Leora
Vanderbilt University


18 Years
Inclusion Criteria:

Availability of tumor tissue for mesothelin expression testing and for further biomarker analysis

Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)

At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (or for thymic carcinoma, at least one measurable lesion per International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 criteria

Adequate bone marrow, liver, renal and coagulation function

Left ventricular ejection fraction (LVEF) ? 50% of the lower limit of normal (LLN) according to local institutional ranges

Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

Exposure to more than one prior anti-tubulin/microtubule agent

Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition

Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis

Contraindication to both CT and MRI contrast agents

Active hepatitis B or C infection

Pregnant or breast-feeding patients

Tumor type specific exclusion criteria

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