A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene

Summary

Participation Requirements

Description

This is a Phase 2, multicenter, single-arm, open label study of AB-106 in the Chinese patients of NSCLC harboring with ROS1 fusion gene. The study will consist of 2 parts. The Part 1 portion will evaluate the safety and PK profile of AB-106 by using two doses of 400mg QD and 600mg QD in order to con...

This is a Phase 2, multicenter, single-arm, open label study of AB-106 in the Chinese patients of NSCLC harboring with ROS1 fusion gene. The study will consist of 2 parts. The Part 1 portion will evaluate the safety and PK profile of AB-106 by using two doses of 400mg QD and 600mg QD in order to confirm 600mg QD as the most optimal dose. The Part 2 portion will evaluate the efficacy and safety of AB-106 by using the most optimal dose of 600mg QD. It is expected to enroll 6 patients in Part 1 and 100 patients in Part 2. The study period of each patient will be comprised of screening, treatment, safety follow-up and survival follow-up. In the Part 1 portion, 3 patients will receive AB-106 400mg QD and 3 patients will receive AB-106 600mg QD in 21-cycles to evaluate the safety and PK profiles. In the Part 2 portion, 100 patients will be enrolled and divided into 2 cohorts. 60 crizotinib-naïve patients will be enrolled in Cohort A and 40 crizotinib-pretreated patients will be enrolled in Cohort B. AB-106 will be administered 600mg once daily in 21-day cycles. Patients will continue with the study treatment until progression of disease as determined by the investigator. The tumor response evaluation will be conducted in every two cycles in the first 8 cycles, and then every four cycles until progression of disease as determined by the investigator. The long-term survival follow up will be conducted every 12 weeks.

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