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