Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AB-106 · 1 trial · 1 indication
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...
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AB-106 is an investigational small molecule being developed for oncology indications, specifically non-small cell lung cancer (NSCLC) and solid tumors. It is currently in Phase 2 clinical development for advanced NSCLC harboring ROS1 fusion gene, and has also been studied in healthy volunteers for pharmacokinetic effects.
AB-106 is being developed by Nuvation Bio Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol NUVB. The company is conducting clinical trials for this investigational oncology drug.
AB-106 is in Phase 2 clinical development. The most advanced trial is a Phase 2 study in patients with advanced non-small cell lung cancer harboring ROS1 fusion gene, which is active but not recruiting. Earlier Phase 1 studies have been completed.
AB-106 has been studied in three clinical trials. The main trial is NCT04395677, a Phase 2 study in 173 patients with advanced NSCLC harboring ROS1 fusion gene in China. Two Phase 1 studies, NCT05357820 and NCT05357911, evaluated drug interactions in healthy volunteers and have been completed.
AB-106 is not FDA approved. It is an investigational drug currently in clinical development. The most advanced trial is a Phase 2 study in non-small cell lung cancer, which is active but not recruiting. No approval status has been reported.
AB-106 targets the ROS1 fusion gene in non-small cell lung cancer. The Phase 2 clinical trial specifically enrolls patients with advanced NSCLC harboring ROS1 fusion gene, indicating that the drug is designed to act on this molecular target.