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

Non Small Cell Lung Cancer Clinical Trial

Official title:
A Multicenter, Open Label, Single Arm Phase 2 Study of AB-106 in the Treatment of Locally Advanced and Metastatic NSCLC

Clinical Trial Summary

The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of AB-106 monotherapy in the treatment of advanced NSCLC.

Clinical Trial Description

This is a Phase II, multicenter, single-arm, open label study of AB-106 in the Chinese patients with advanced NSCLC harboring ROS1 fusion gene.The study will be divided into two stages. First stage (Stage I) is to determine the clinical optimal dose of AB-106, which will be evaluated at two dose levels (400 mg QD and 600mg QD), and the safety, tolerability and pharmacokinetics of AB-106 will be evaluated at the same time; Second stage (Stage II) is to evaluate the efficacy and safety of AB-106 at the clinical optimal dose determined from Stage I. It is expected that 6 patients with advanced NSCLC harboring ROS1 fusion will be enrolled in the first stage. About 167 patients with ROS1 fusion will be enrolled in the second stage and divided into two treatment cohorts (Cohort A & Cohort B). It is planned to enroll about 106 ROS1-TKI treatment naïve patients in Cohort A and about 67 crizotinib pre-treated patients 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 6 weeks in the first 8 cycles, and then every 12 weeks until progression of disease as determined by the investigator. The long-term survival follow up will be conducted every 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04395677
Study type Interventional
Source AnHeart Therapeutics Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 7, 2020
Completion date December 31, 2025
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