Official Title
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
Phase
Phase 1Lead Sponsor
Centaurus Biopharma Co., Ltd.Study Type
InterventionalStatus
Unknown statusIndication/Condition
Non-small Cell Lung CancerIntervention/Treatment
ct-707 ...Study Participants
40This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer.
The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.
ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
Inclusion Criteria: Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally. Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1 Availability of tumor sample: Exclusion Criteria: Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease. Other protocol-defined inclusion/exclusion criteria may apply.
