NCT04395677

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Nuvation Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 frequency of tumor assessments is once every 2 treatment cycles through Cycle 9, then every 3 treatment cycles through Cycle 27 and every 4 treatment cycles thereafter.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AB-106	Stage 1: 400mg QD for 3 patients and 600mg QD for 3 patients Stage 2: 600mg QD

Timeline

• Start date: 2020-07-07
• Primary completion: 2024-06-07
• Completion: 2027-06-01
• First posted: 2020-05-20
• Last updated: 2026-02-06

Locations

1 site across 1 country: China