A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene
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ClinicalTrials.gov Identifier: NCT04395677 |
Recruitment Status :
Active, not recruiting
First Posted : May 20, 2020
Last Update Posted : October 30, 2023
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Condition or disease | Intervention/treatment | Phase |
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Non Small Cell Lung Cancer | Drug: AB-106 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 173 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Open Label, Single Arm Phase 2 Study of AB-106 in the Treatment of Locally Advanced and Metastatic NSCLC |
Actual Study Start Date : | July 7, 2020 |
Estimated Primary Completion Date : | December 30, 2023 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
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Experimental: AB-106 (DS-6051b)
Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106
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Drug: AB-106
Stage 1: 400mg QD for 3 patients and 600mg QD for 3 patients Stage 2: 600mg QD Other Name: DS-6051b |
- 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
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 25 months ]Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- 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
- Maximum Plasma Concentration [Cmax] [ Time Frame: Day 1 to Cycle1Day15 ]The Cmax of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)
- 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)
- 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)
- Trough plasma concentration [Ctrough] [ Time Frame: Day 1 to Cycle1Day15 ]The Cthrough of Cycle1Day1 and Cycle1Day15 will be assessed, (each cycle is 21 days)
- 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)
- 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
- 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
- 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.
- 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
- 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
- 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
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395677
China, Shanghai | |
Shanghai Pulmonary Hospital | |
Shanghai, Shanghai, China, 200000 |
Study Director: | Oncology | Shanghai Pulmonary Hospital, Shanghai, China |
Responsible Party: | AnHeart Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT04395677 |
Other Study ID Numbers: |
AB-106-C203 |
First Posted: | May 20, 2020 Key Record Dates |
Last Update Posted: | October 30, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |