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

NCT04395677 | Active Not Recruiting Phase 2

• 1 other identifier: AB-106-C203
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Best overall response (BOR) by IRC

  Best overall response (BOR) based on independent radiology review by Independent Review Committee(IRC) according to RECIST 1.1

  6 months

Secondary Outcomes (14)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  25 months

• Rate of ECG QT Interval prolongation patients in all patients

  25 months

• Maximum Plasma Concentration [Cmax]

  Day 1 to Cycle1Day15

• Area under the curve from time zero to τ (dose interval τ is 24 h in this study) [AUCτ]

  Day 1 to Cycle1Day15

• Average plasma concentration at steady state over dosing interval [Cav]

  Day 1 to Cycle1Day15

Study Arms (1)

AB-106 （DS-6051b）

EXPERIMENTAL

Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106

Drug: AB-106

Interventions

AB-106 DRUG

Stage 1: 400mg QD for 3 patients and 600mg QD for 3 patients Stage 2: 600mg QD

Also known as: DS-6051b

AB-106 （DS-6051b）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria to be eligible for enrollment into the study:
• ≥ 18 years of age
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC
• Positivity of ROS1 fusion is determined by the local qualified laboratories by using the FISH, RT-PCR or NGS assay, and the subject must provide archival tumor tissue sample for the confirmation by a sponsor-designated central laboratory
• The subject is either TKI treatment naïve(Cohort A)， or has disease progression following the treatment of crizotinib （Cohort B）
• The patient with brain metastases is either asymptomatic, or neurologically stable for at least 2 weeks prior to study entry
• Prior therapies (including chemotherapies \[less than 3 lines of regimen\], radiotherapy \[except for palliative\], or surgery) should be completed at least 2 weeks prior to study entry. The palliative radiotherapy (≤10 times) should be completed within 48 hours prior to study entry. Any acute toxic effect must be resolved to CTCAE Grade ≤1 except for alopecia
• At least one measurable target tumor lesion (as accessed by RECIST v1.1) that has not been irradiated
• ECOG Performance Status: 0 or 1
• Patient with a life expectancy ≥ 3 months based on the judgement of investigators
• Adequate organ functions defined by the following criteria：
• Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤2.5 x ULN; or ≤5 x ULN， if there is liver metastases involvement；
• Total serum bilirubin ≤1.5 x ULN；
• Absolute neutrophil count（ANC） ≥1500/µL；
• Platelet count≥100,000/µL；

You may not qualify if:

• Patient presenting with any of the following criteria will not be included in the study：
• Current participation in other therapeutic investigational studies
• Previous participation in the treatment or clinical trials of other ROS1-TKIs (except for crizotinib)
• Previous participation in the treatment and clinical trials of ALK or NTRK fusion gene targeted therapies.
• Spinal cord compression unless the patient demonstrates good pain control and stabilization or recovery of neurological function, carcinomatous meningitis or leptomeningeal disease
• Patients with interstitial fibrosis or interstitial lung disease
• Any one of the following currently or in the previous 3 months: myocardial infarction, severe/unstable angina, coronary/ peripheral artery bypass graft, congestive heart failure or cerebrovascular accident including transient ischemic attack
• Ongoing cardiac dysrhythmias of NCI CTCAE (v5.0) Grade≥2, uncontrolled atrial fibrillation of any grade, or QTc interval\>470 microsec
• Pregnancy or breastfeeding
• Current use of food or drugs that are known strong CYP3A inhibitors, including (but not limited to) atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit or grapefruit juice.
• Current use of drugs that are known strong CYP3A4 inducers, including (but not limited to) carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St John's Wort
• Current use of drugs that are known CYP3A4 substrates with narrow therapeutic indices, including (but not limited to) dihydroergotamine, ergotamine, pimozide, astemizole, cisapride, and terfenadine.
• Current use of drugs that are known to induce QTc prolongation
• Systematic treatment with anti-cancer therapy, including any Traditional Chinese Medicine (TCM)with anti-tumor effect indicated in the prescription information.
• Evidence of active malignancy (other than current NSCLC, non-melanoma skin cancer, in situ cervical cancer, and presumed cured prostate cancer) within the last 3 years

Sponsors & Collaborators

• Nuvation Bio Inc.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (2)

• Perol M, Li W, Pennell NA, Liu G, Ohe Y, De Braud F, Nagasaka M, Felip E, Xiong A, Zhang Y, Fan H, Wang X, Li S, Lai RK, Ran F, Zhang X, Chen W, Bazhenova L, Zhou C. Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST. J Clin Oncol. 2025 Jun;43(16):1920-1929. doi: 10.1200/JCO-25-00275. Epub 2025 Apr 3.

  PMID: 40179330 DERIVED

• Li W, Xiong A, Yang N, Fan H, Yu Q, Zhao Y, Wang Y, Meng X, Wu J, Wang Z, Liu Y, Wang X, Qin X, Lu K, Zhuang W, Ren Y, Zhang X, Yan B, Lovly CM, Zhou C. Efficacy and Safety of Taletrectinib in Chinese Patients With ROS1+ Non-Small Cell Lung Cancer: The Phase II TRUST-I Study. J Clin Oncol. 2024 Aug 1;42(22):2660-2670. doi: 10.1200/JCO.24.00731. Epub 2024 Jun 1.

  PMID: 38822758 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oncology

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 20, 2020
• Study Start: July 7, 2020
• Primary Completion: June 7, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)