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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGIncidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
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
Time frame: 28 days
Frequency of adverse events/serious adverse events
Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
Time frame: Up to 24 months
Overall Response Rate (ORR) - Phase I
Preliminary measure of anti-tumor activity of CT-707
Time frame: Up to 24 month
Progression free survival (PFS) per RECIST v1.1 - Phase I
Preliminary measures of anti-tumor activity of CT-707
Time frame: Up to 24 months
Duration of response (DOR)
Preliminary measure of anti-tumor activity of CT-707
Time frame: Up to 24 months
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