- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: AnHeart Clinical Development
- Phone Number: +86 10 65211007
- Email: smwang@anhearttherapeutics.com
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200000
- Shanghai Pulmonary Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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;
- Hemoglobin≥8.0 g/dL;
- Serum creatinine ≤2 x ULN. 11. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of the pertinent aspect of the study 12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures 13. Male and female patients of childbearing potential must agree to sue effective methods of contraception throughout the study and for 90 days after the last dose of study medication.
Exclusion Criteria:
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
- Clinically active viral disease with positivity of serum HIV, HBV, HCV, RPR testing
- Difficult to swallow which may significantly impact drug absorption
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation in the judgement of investigator and sponsor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AB-106 (DS-6051b)
Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106
|
Stage 1: 400mg QD for 3 patients and 600mg QD for 3 patients Stage 2: 600mg QD
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best overall response (BOR) by IRC
Time Frame: 6 months
|
Best overall response (BOR) based on independent radiology review by Independent Review Committee(IRC) according to RECIST 1.1
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 25 months
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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
Time Frame: 25 months
|
After the medicine, the number of patients with ECG QT Interval and the rate of patients with clinical significant
|
25 months
|
Maximum Plasma Concentration [Cmax]
Time Frame: Day 1 to Cycle1Day15
|
The Cmax of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)
|
Day 1 to Cycle1Day15
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Area under the curve from time zero to τ (dose interval τ is 24 h in this study) [AUCτ]
Time Frame: Day 1 to Cycle1Day15
|
The AUCτ of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)
|
Day 1 to Cycle1Day15
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Average plasma concentration at steady state over dosing interval [Cav]
Time Frame: Day 1 to Cycle1Day15
|
The Cav of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)
|
Day 1 to Cycle1Day15
|
Trough plasma concentration [Ctrough]
Time Frame: Day 1 to Cycle1Day15
|
The Cthrough of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)
|
Day 1 to Cycle1Day15
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Time to reach maximum plasma concentration [Tmax]
Time Frame: Day 1 to Cycle1Day15
|
The Tmax of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)
|
Day 1 to Cycle1Day15
|
Duration of Response(DOR)
Time Frame: 25 months
|
Duration of Response(DOR) based on independent radiology review by Independent Review Committee(IRC) and investigator according to RECIST 1.1
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25 months
|
Time to Response(TTR)
Time Frame: 6 months
|
Time to Response(TTR) based on independent radiology review by Independent Review Committee(IRC) and investigator according to RECIST 1.1
|
6 months
|
Time to Progress(TTP)
Time Frame: 25 months
|
Time to Progress(TTP) based on independent radiology review by Independent Review Committee(IRC) and investigator according to RECIST 1.1 OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. |
25 months
|
Progression free Survival(PFS)
Time Frame: 25 months
|
Progression free Survival(PFS) based on independent radiology review by Independent Review Committee(IRC) and investigator according to RECIST 1.1
|
25 months
|
Intracranial best overall response (IBOR)
Time Frame: 25 months
|
Intracranial Best overall response (BOR) based on independent radiology review by Independent Review Committee(IRC) and Investigator according to RANO for intracranial lesion
|
25 months
|
Duration of intracranial response (IDOR)
Time Frame: 25 months
|
Duration of intracranial response (IDOR) based on independent radiology review by Independent Review Committee(IRC) and Investigator according to RANO for intracranial lesion
|
25 months
|
Overall Survival(OS)
Time Frame: 51 months
|
OS defined as the time from randomization to death from any cause.
Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
|
51 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Oncology, Shanghai Pulmonary Hospital, Shanghai, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AB-106-C203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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