Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors

Study summary

Determine the safety, tolerability and maximum tolerated dose of anetumab ravtansine (BAY 94-9343) in combination with pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 in subjects with mesothelin-expressing predominantly epithelial mesothelioma or nonsquamous non-small-cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBAY 94-9343 and Pemetrexed

Plus 1 other study approaches.

Who it may be forMesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 7, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Bayer

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Bayer
Interventions being studied: Drug: BAY 94-9343; Drug: Pemetrexed; Drug: Cisplatin

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Mesothelioma→

Treatment approach

Chemotherapy→

Public criteria

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.

Requirements people may need to meetInclusion criteria

Subjects may be male or female, and must be aged =/\>18 years on the date of signing the informed consent form.
Subjects must have histologically confirmed, unresectable, locally advanced or metastatic pleural or peritoneal predominantly (\>50% of tumor component) epithelial mesothelioma or nonsquamous non-small-cell lung cancer (NSCLC). Both chemotherapy-naive and previously treated subjects will be eligible; however, newly diagnosed NSCLC subjects eligible for FDA-approved therapies should have received the same before enrollment (e.g. subjects with epidermal growth factor receptor \[EGFR\]-mutated and anaplastic lymphoma kinase \[ALK\]-translocated NSCLC should have received FDA-approved targeted therapies).
Subjects must have at least 1 measurable or evaluable tumor lesion according to RECIST 1.1 (for nonsquamous NSCLC) or mRECIST (for epithelial pleural mesothelioma). Subjects with resected primary tumors who have documented metastases are eligible.
Subjects must have a life expectancy of at least 12 weeks.
Subjects must have ECOG (Eastern Cooperative Oncology Group performance Status of 0 or 1
Subjects must have adequate bone marrow, liver, kidney, and coagulation functions.

Reasons someone may not be able to joinExclusion criteria

Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, or any previous cancer curatively treated \>3 years before the start of study Treatment.
Subjects who have a history or current evidence of bleeding disorder, i.e. any hemorrhage / bleeding event of CTCAE (Common Terminology Criteria for Adverse Events) Grade ≥2 within 4 weeks before the start of study Treatment.
Subjects who have new or progressive brain or meningeal or spinal metastases.
Subjects who have a history or current evidence of uncontrolled cardiovascular disease i.e. NYHA (New York Heart Association) Class III or IV.
Subjects who have a history or current evidence of uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening despite optimal medical management.
Subjects who have a history or current evidence of malignant biliary obstruction requiring biliary stent.
Subjects who have had solid organ or bone marrow Transplantation.
Subjects who have a history of hypersensitivity to any of the study drugs or their excipients, or a history of severe hypersensitivity to any other Antigen.
Subjects who have a history of human immunodeficiency virus (HIV) infection or subjects who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment.
Subjects who have an active clinically serious infection of CTCAE Grade ≥2 or non-healing wound unrelated to the primary Tumor.
Subjects who have received systemic cancer therapy, radiotherapy, investigational drug treatment outside of this study within 4 weeks before the start of study treatment, granulocyte colony stimulating factors, (G-CSF) or granulocyte macrophage-stimulating factors (GM-CSF), erythropoietin-stimulating agents within 3 weeks before the start of general screening, drugs with known renal toxicity and strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the treatment.
Subjects who have started oral or parenteral anticoagulation therapy within 2 weeks before the start of anetumab ravtansine until end of treatment visit.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Study locationChicago, Illinois
Study locationBethesda, Maryland
Study locationDetroit, Michigan
Study locationCharleston, South Carolina
Study locationMilan, Lombardy
Study locationMilan, Lombardy

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 7, 2019. Always confirm current availability with the study team.

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