Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
Study Details
Study Description
Brief Summary
This 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CT-707 ALK-positive non-small cell lung cancer resistant to Crizotinib treatment |
Drug: CT-707
|
Outcome Measures
Primary Outcome Measures
- Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I) [28 days]
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-707 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days
- Frequency of adverse events/serious adverse events [Up to 24 months]
Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
Secondary Outcome Measures
- Overall Response Rate (ORR) - Phase I [Up to 24 month]
Preliminary measure of anti-tumor activity of CT-707
- Progression free survival (PFS) per RECIST v1.1 - Phase I [Up to 24 months]
Preliminary measures of anti-tumor activity of CT-707
- Duration of response (DOR) [Up to 24 months]
Preliminary measure of anti-tumor activity of CT-707
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital of Chinese Academy of Medical Sciences | Beijing | Beijing | China | 100021 |
Sponsors and Collaborators
- Centaurus Biopharma Co., Ltd.
Investigators
- Principal Investigator: Yuankai Shi, Dr, Cancer Hospital of Chines Academy of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT-707-101