Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04395677 | A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene | PHASE2 | ACTIVE NOT_RECRUITING | 173 | — | — | Jul 7, 2020 | Jun 1, 2027 | Feb 6, 2026 | 1 | China |
Best overall response (BOR) based on independent radiology review by Independent Review Committee(IRC) according to RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| AB-106 （DS-6051b） | EXPERIMENTAL | Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106 |
| Name | Type | Description |
|---|---|---|
| AB-106 | DRUG | Stage 1: 400mg QD for 3 patients and 600mg QD for 3 patients Stage 2: 600mg QD |
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment into the study: 1. ≥ 18 years of age 2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC 3. Positivity of ROS1 fusion is determined by the local qualified laboratories b...