Site for Phase II, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer
This study is to determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ non-small cell lung cancer.
Medical/Oncology history – questions will be asked regarding your health problems, details of your lung cancer diagnosis and previous treatment and questions regarding tobacco and alcohol use. • Physical exam • Vital signs – (check your blood pressure, heart rate, and temperature), weight, and height. • Blood and urine tests to monitor your health: o Routine blood tests (approximately 2.5 teaspoons or 12.5 mL of blood) to check your blood counts (numbers of each type of blood cell), chemistries (elements and minerals in your blood), blood clotting, testosterone and sex hormone binding globulin (males only) and how well your organs are functioning. o Routine urine tests • Pregnancy Test (only for females who are able to get pregnant – done on the blood tube collected for routine blood tests) - For post-menopausal women less than 55 years old, a serum pregnancy test including FSH levels (a hormone) will be collected at screening. o If confirmed post-menopausal, no additional pregnancy testing is required. o The study doctor or study staff will tell you if the pregnancy test results are positive. o The results of the pregnancy testing must be negative in order for you to be in the study. • Electrocardiogram (ECG) - an ECG measures the electrical activity of your heart. • Review of any medications you are taking – questions will be asked about any prescribed and over the counter medications/supplements that you are taking. • Evaluate your performance status (your ability to perform daily activities) - your study doctor will assess and assign a score based on your ability to perform daily tasks by asking questions. • Computed Tomography (CT)/ Magnetic Resonance Imaging (MRI) Scan – A CT scan of the full chest and abdomen is the preferred way of measuring your cancer (it may include neck and pelvis, when clinically required). A CT scan uses radiation (x-rays) to make pictures of the inside of your body. The scan can show more details or even larger areas to show organs and structures in 3 dimensions (“3-D”). o The study doctor or study staff may give you a contrast dye, either by mouth or with a needle. The study doctor or study staff can tell you more about the contrast dye. • MRI scan – If you are unable to undergo CT scan your study doctor may have a MRI scan taken instead. For most people, there is no danger associated with having a MRI scan. However, a MRI could be very dangerous if you have certain objects or devices (usually metal) implanted in your body, such as a pacemaker, insulin pump, ear implant, joint replacement, surgical clips, permanent dentures, piercings, or shrapnel. o You must tell the study doctor or study staff about any objects that you know are implanted or embedded in your body. Some people may feel claustrophobic, so tell the study staff if you are claustrophobic. • Magnetic Resonance Imaging (MRI) Scan of your brain – A Computed Tomography (CT) scan with contrast may be done if an MRI scan is contraindicated. If you have had an MRI/CT scan done recently as part of your regular medical care, an additional scan may not be needed. • Tumor Material – If you qualify for participation in the study based on c-Met positive status, additional tumor material may have to be obtained during the Screening period in order to participate in the study. Your study doctor will discuss the details with you.
Subjects must have c-Met+ NSCLC as assessed by an AbbVie designated IHC laboratory or known documented MET gene amplification
Subjects have adequate bone marrow, renal, and hepatic function
Subjects are willing and able to comply with procedures required in this protocol
Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Subjects must not have psychiatric illness/social situation that would limit compliance with the study
Subjects must not have any medical condition which in the opinion of the Investigator or Therapeutic Area Medical Director (TA MD) places the subject at an unacceptably high risk for toxicities
Subjects must not have received any live vaccine within 30 days of the first dose of investigational product
Subjects must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin