Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine for Mesothelin Expressing Lung Adenocarcinoma

Stopped early · Phase 2

Conditions studied: Lung Neoplasms

In brief

Background: Anetumab ravtansine is a new drug. It kills cancer cells that carry mesothelin. That is a protein on the surface of tumor cells in many types of tumors, including most lung cancers. Researchers want to find a safe dose for the study drug for lung cancer. They want to see if it can shrink tumors in mesothelin-positive lung cancer. Objectives: To test the safety and effectiveness of anetumab ravtansine for lung cancer. Eligibility: Adults 18 years and older who have lung cancer that has gotten worse on other therapy Design: Participants will be screened with: Medical history Physical exam Tumor tissue sample. This can be from a previous procedure. Blood and urine tests Heart tests Scans. For one scan, a small amount of radioactive substance is injected into the blood. Eye exam The study will have 21-day cycles. On day 1 of each cycle, participants will get the study drug through a tube inserted in a vein. Participants will repeat a heart test in cycles 1 and 2. They will have blood tests weekly in cycle 1, twice in all other cycles. They will have scans every 6 weeks for the first 6 months, every 9 weeks until the end of year 2, then every 12 weeks. Participants will have samples of tumor tissue taken twice. About 30 days after stopping the study drug, participants will have a follow-up visit. This will include medical history, physical exam, blood and pregnancy tests, and heart and eye tests. Some will be called a few times a year to discuss their health and treatment.

Key facts

Study ID

NCT02839681

Run by

National Cancer Institute (NCI)

People needed

2

Starts

2016-07-19

Expected to finish

2018-07-25

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from lung adenocarcinoma, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated <2 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 Common Terminology Criteria in Adverse Events (CTCAE) Grade greater than or equal to 2 within 4 weeks before the start of study treatment.
• History of symptomatic metastatic brain or meningeal tumors unless the subject is > 3 months from definitive therapy and has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry. Subjects with brain metastases must not be undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for one month prior to screening.
• Subjects who have a history or current evidence of uncontrolled cardiovascular disease including but not limited to the following conditions:
• Congestive heart failure of New York Heart Association (NYHA) Class III or IV
• Unstable angina (symptoms of angina at rest) or new-onset angina within <3 months before the start of study treatment.
• Arterial thrombosis, deep vein thrombosis, or pulmonary embolism within <3 months before the start of study treatment.
• Myocardial infarction or stroke within <3 months before the start of study treatment.
• Pericarditis (any CTCAE grade), pericardial effusion (CTCAE Grade greater than or equal to 2) or pleural effusion (CTCAE Grade greater than or equal to 2)
• Cardiac arrhythmia requiring anti-arrhythmic therapy. Subjects receiving digoxin, calcium channel blockers except verapamil, or beta-adrenergic blockers except propranolol are eligible at the investigators discretion if the dose has been stable for at least 2 weeks before the start of study treatment. Subjects with sinus arrhythmia and infrequent premature ventricular contractions are eligible at the investigators discretion.
• Subjects who have a left ventricular ejection fraction (LVEF) <50%, as assessed by echocardiogram performed at screening.
• Subjects who have a corrected Q wave, T wave (QT) (corrected QT interval by Fredericia (QTcF)) interval >480 ms (CTCAE Grade >1) determined by the electrocardiogram (ECG) recorders algorithm on the screening ECG.
• Subjects who have a history or current evidence of uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg at screening despite optimal medical management. Subjects with a history of mild to moderate
• hypertension are eligible at the investigator s discretion if the hypertension is adequately controlled by antihypertensive treatment used at a stable dose for at least 2 weeks before the start of study treatment.
• Subjects who have a heart rate greater than or equal to 100 beats per minute (bpm) or less than or equal to 45 bpm determined by the ECG recorder s algorithm on the screening ECG.
• Women who are pregnant or breast-feeding. Women of reproductive potential must have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test obtained within 7 days before the start of study treatment.
• Subjects who have had a major surgery or significant trauma within 4 weeks before the start of study treatment.
• 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 due to a theoretical concern that the degree of immune suppression associated with the treatment may result in progression of HIV infection. Subjects with chronic HBV or HCV infection are eligible at the investigators discretion if the subject is considered non-infectious based on serological markers.
• Subjects who have an active clinically serious infection of CTCAE Grade greater than or equal to 2.
• Subjects with a non-healing serious wound, ulcer, or bone fracture unrelated to the primary tumor.
• Subjects with corneal epitheliopathy or any eye disorder that may predispose the subjects to drug-induced corneal epitheliopathy, or may interfere with diagnosis of treatment-emergent corneal epitheliopathy at the discretion of the investigator in consultation with the ophthalmologist/optometrist. Low grades of superficial punctate keratitis, within the range seen in the normal population, should not lead to the exclusion of the patient
• Subjects experiencing unresolved toxicity of previous antitumor therapy which is CTCAE Grade >1 before the start of study treatment, except for alopecia or hemoglobin greater than or equal to 9.0 g/dL or greater than or equal to 5.6 mmol/L.
• Subjects with any clinical condition that is considered unstable or might jeopardize the safety of the subject and/or influence the subjects compliance in the study.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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