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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jun 30, 2022 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Bayer
- Interventions being studied
- Drug: Cisplatin; Drug: Gemcitabine; Drug: Anetumab ravtansine (BAY94-9343)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic HospitalPhoenix, Arizona
- University of Southern CaliforniaLos Angeles, California
- Stanford Health CareStanford, California
- MedStar Georgetown University HospitalWashington D.C., District of Columbia
- Indiana University School of MedicineIndianapolis, Indiana
- Ochsner Medical Center - New OrleansNew Orleans, Louisiana
- National Cancer Institute - MarylandBethesda, Maryland
- Barbara Ann Karmanos Cancer InstituteFarmington Hills, Michigan
- Mayo Clinic - RochesterRochester, Minnesota
- Washington University School of MedicineSt Louis, Missouri
- Vanderbilt University Medical CenterNashville, Tennessee
- Texas Oncology, PADallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 30, 2022. Always confirm current availability with the study team.