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Trial record 2 of 2 for:    AB106

Basket Study of AB-106 for the Treatment of Patients With Solid Tumors With NTRK Fusion Gene

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ClinicalTrials.gov Identifier: NCT04617054
Recruitment Status : Not yet recruiting
First Posted : November 5, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
AnHeart Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE October 30, 2020
First Posted Date  ICMJE November 5, 2020
Last Update Posted Date March 17, 2021
Estimated Study Start Date  ICMJE March 31, 2021
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
Best overall response (BOR) [ Time Frame: Approximately 24 months ]
Assessed by Independent Review Committee (IRC) using RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
  • Best overall response (BOR) [ Time Frame: Approximately 24 months ]
    Assessed by Investigator using RECIST v1.1Investigator.
  • Duration of response (DOR) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1
  • Time to Response (TTR) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1
  • Time to Progress (TTP) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1
  • Intracranial best overall response (IBOR) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RANO for subjects with intracranial metastasis at baseline.
  • Intracranial Duration of intracranial response (IDOR) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RANO for subjects with intracranial metastasis at baseline.
  • Progression free Survival (PFS) [ Time Frame: Approximately 30 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1
  • Overall survival (OS) [ Time Frame: Approximately 36 months ]
    Assessed by Kaplan-Meier method
  • Adverse events (AE) [ Time Frame: Approximately 36 months ]
    Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE 5.0
  • Plasma drug concentration (PK) [ Time Frame: Approximately 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Basket Study of AB-106 for the Treatment of Patients With Solid Tumors With NTRK Fusion Gene
Official Title  ICMJE A Phase II, Multicenter, Open, Basket Study of AB-106 to Treat the Subjects With Local Progression or Systemic Metastasis Solid Tumors With NTRK Gene Fusion
Brief Summary

This study will evaluate the efficacy and safety of AB-106 in the treatment of solid tumors with NTRK fusion gene.

AB-106 was given once a day, each treatment cycle was 21 days, continuous medication. Until the researchers identified disease progression, intolerable drug-related adverse events, researchers recommended discontinuation of treatment, withdrawal of informed consent, pregnancy during the study, use of other anti-tumor therapy, loss of follow-up, death and other causes, whichever occurs first.

The study included screening period, treatment period, safety follow-up and long-term follow-up.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: AB-106
600mg QD for each subjects.
Study Arms  ICMJE Experimental: Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106
Intervention: Drug: AB-106
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of locally advanced or systemic metastatic solid tumors with NTRK1/2/3 fusion gene;
  2. Subjects who failed or refused to accept the standard treatment;
  3. At least one measurable target tumor lesion as accessed by RECIST v1.1;
  4. Subjects diagnosed with primary CNS tumors should meet the following criteria: (1) Received previous treatment, including radiotherapy, chemotherapy, targeted therapy; (2) At least one measurable lesion by two-dimensional measurement (confirmed by MRI and using RANO). At least one measurable lesion in each dimension should be ≥ 1cm and on more than one image; (3) The imaging exam should be completed within 28 days before dosing, and the disease should be in stable;
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  6. Minimum life expectancy of 3 months;
  7. Adequate organ function defined per protocol;
  8. Coagulation function: international standardized ratio (INR) ≤ 1.5, and partial prothrombin time (PT) or activated partial prothrombin time (APTT) ≤ 1.5 × ULN (Upper limit of normal);
  9. For patients enrolled via local molecular testing, an archival or fresh tumor tissue is required to be submitted for independent central molecular testing;
  10. Any toxic effect caused by prior therapies must be recovered to CTCAE Grade ≤1 except for alopecia.

Exclusion Criteria:

  1. Current participation in another therapeutic clinical trial within 4 weeks before first dose;
  2. Prior treatment with NTRK fusion gene and immune checkpoint inhibitors (including PD-1/PD-L1, etc.);
  3. Subjects with symptomatic or unstable brain metastasis (asymptomatic brain metastasis subjects can be selected for) and CNS primary tumor, but need to be in stable for at least 7 days, will be enrolled;
  4. Had major surgery or radiotherapy within one month before the first dose, or were expected to need a major surgery during study;
  5. Pneumonia caused by interstitial lung disease, interstitial fibrosis, or tyrosine kinase inhibitors;
  6. Active and uncontrollable systemic bacterial, viral or fungal infectionsx;
  7. Clinically active viral disease with positivity of serum HIV, HBV, HCV testing;
  8. Historical immunodeficiency, including acquired, congenital immunodeficiency diseases, or a historical organ transplant;
  9. The systematically use of strong CYP3A inhibitors, including ( but not limited to) atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit or grapefruit juice;
  10. The systematically use of strong CYP3A inducers, including ( but not limited to) carbamazepine, phenobarbital, phenytoin, rifampicin, rifampicin and St. John's grass;
  11. Any other anti-tumor drug use within 14 days before first dose or during the study;
  12. Historical, neurological or mental disorders, such as epilepsy or dementia;
  13. Historical drug abuse;
  14. Spinal cord compression caused by tumor (unless the subject's pain is completely controlled and neurological function is stable or restored),cancerous meningitis or leptomeningeal disease; have risk of cerebral hernia determined by investigator;
  15. Active gastrointestinal or other malabsorption disease, such as gastrectomy or enterectomy;
  16. With 3 months before first dose, have unstable cardiovascular disease like as, myocardial infarction, severe / unstable angina pectoris, coronary artery / peripheral artery bypass grafting, congestive heart failure (NCICTCAEv5.0 ≥ 3), arrhythmia (NCICTCAEv5.0 ≥ 2), uncontrollable atrial fibrillation (arbitrary grade) or female QTcF > 470ms or male QTcF > 450ms;
  17. Cerebrovascular accidents (exclude transient ischemic attacks) occurred within 3 months before first dose;
  18. Other malignant tumors, exclude cured non-melanoma skin cancer, cervical cancer in situ and prostatic intraepithelial neoplasia;
  19. Other protocol specified criteria accessed by investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shuangmiao Wang 08610-65211007 smwang@anhearttherapeutics.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04617054
Other Study ID Numbers  ICMJE AB-106-C205
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AnHeart Therapeutics Inc.
Study Sponsor  ICMJE AnHeart Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AnHeart Therapeutics Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP