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Trial record 1 of 1 for:    NCT04617054
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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 : Recruiting
First Posted : November 5, 2020
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
AnHeart Therapeutics Inc.

Brief Summary:

AB-106 will be administered once a day. Each treatment cycle is defined as 21 days of continuous medication. Dosing will continue until any of the following conditions are met: disease progression, intolerable drug-related adverse events, researchers recommend 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 includes a screening period, treatment period, safety follow-up and long-term follow-up.


Condition or disease Intervention/treatment Phase
Solid Tumor Drug: AB-106 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 1, 2021
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single-arm trial whereby all consented, enrolled, eligible patients receive AB-106 Drug: AB-106
600mg QD for each subjects.




Primary Outcome Measures :
  1. Best overall response (BOR) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) using RECIST v1.1


Secondary Outcome Measures :
  1. Best overall response (BOR) [ Time Frame: Approximately 24 months ]
    Assessed by Investigator using RECIST v1.1Investigator.

  2. Duration of response (DOR) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1

  3. Time to Response (TTR) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1

  4. Time to Progress (TTP) [ Time Frame: Approximately 24 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1

  5. 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.

  6. 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.

  7. Progression free Survival (PFS) [ Time Frame: Approximately 30 months ]
    Assessed by Independent Review Committee (IRC) and Investigator using RECIST v1.1

  8. Overall survival (OS) [ Time Frame: Approximately 36 months ]
    Assessed by Kaplan-Meier method

  9. 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

  10. Plasma drug concentration (PK) [ Time Frame: Approximately 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT04617054


Contacts
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Contact: Shuangmiao Wang 08610-65211007 smwang@anhearttherapeutics.com

Locations
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China
Chinese PLA General Hospital Recruiting
Beijing, China
Contact: Jianming Xu         
Sponsors and Collaborators
AnHeart Therapeutics Inc.
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Responsible Party: AnHeart Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04617054    
Other Study ID Numbers: AB-106-C205
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms