About the study

The study comprises two phases: phase I dose escalation (including PK run-in period and treatment period) and phase II study.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Phase I dose escalation : the patients with advanced ALK-positive malignant solid tumor who have progressed on standard therapies; Phase I study: histologically or cytologically confirmed, locally advanced ALK-positive and/or metastatic stage IIIB/IV NSCLC who have progressed on standard therapy; Phase II study: histologically or cytologically confirmed, locally advanced ALK-positive or ROS1-positive and/or metastatic stage IIIB/IV NSCLC who have progressed on standard therapy; cohort 1: ALK inhibitor pre-treated patients cohort 2: 1 line ROS-1 inhibitor or standard chemotherapy pre-treated patients cohort 3: ALK inhibitor-naive or ROS1-naive patients
2. At least one measurable lesion per RECIST1.1; Note: a lesion previously treated by radiotherapy is not considered as a target lesion, unless confirmed progression is documented after radiotherapy.
3. ECOG performance score ≤ 2;
4. Male or female patients ≥ 18 and ≤ 75 years old in Phase I ；Male or female patients ≥ 18 in Phase II
5. Life expectancy ≥ 12 weeks;
6. Patient with appropriate organ function as documented by:
7. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
8. Hemoglobin ≥ 90 g/L;
9. Platelets (PLT) ≥ 100 × 109/L
10. Serum total bilirubin ≤ 1.5 × ULN (if the patient has Gilbert's syndrome, ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN);
11. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patient with liver metastases);
12. Creatinine clearance (CrCL) ≥ 50 mL/min (calculated by Cockcroft-Gault equation)
13. Fasting blood glucose ≤ 200 mg/dL (≤ 11.1 mmol/L)
14. Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 per NCI-CTCAE (Version 4.03), exception of alopecia;

Exclusion criteria

1. Has had prior chemotherapy, anti-cancer treatment with biological drugs, or other investigational agents within 28 days or received TKI or targeted therapies within 14 days prior to enrollment;
2. Received radiotherapy within 21 days prior to the 1st dose or continuance of toxicities due to prior radiotherapy that do not recover to Grade 0 or 1;
3. Patients who received major surgery within 3 weeks before enrollment or have not adequately recovered from prior surgery;
4. Patients with central nervous system (CNS) metastases requiring
5. Clinical local intervention such as surgical excision, radiotherapy or other therapies
6. Phase I dose escalation: patients requiring systemic treatment with corticosteroids (>10 mg/day prednisone or equivalent) are not eligible for dose escalation study (not applicable to patients participating Phase I cohort expansion or Phase II).
7. Patients who are taking the following medicines:
8. Repaglinide (cytochrome [CYP]2C8) and drugs metabolized via CYP3A4 enzyme within 1 week before enrollment;
9. Medicines which are known to cause QT prolongation or torsade de pointes;
10. Coumarin anticoagulants within 1 week before enrollment (low molecular weight heparin is permitted);
11. Illegal drugs;
12. Has a history of acute pancreatitis within 1 year before enrollment, or past history of chronic pancreatitis;
13. Patients have positive laboratory test for anti-HCV, or are diagnosed with human immunodeficiency virus (HIV) infection, or who refuse to receive HIV screen test; 9) Patients have other malignant tumor history or with other malignant tumors simultaneously; 10) Patients with cardiac function impairment or clinically significant heart diseases; 11) Corrected QT interval using Fridericia formula > 450 msec for male patients and > 470 msec for female patients; 12) Patients have uncured interstitial lung disease history or non-infectious pneumonitis prior to enrollment, except for those induced by radiation therapy;

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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