Non-small cell lung cancer
Conditions
Interventions
single arm:CT-3505 capsule
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Aged >=18 years; 2) Gender: male or female; 3) The ECOG PS score is 0 to 1 point; 4) The expected survival period is not less than 12 weeks; 5) According to RECIST V1.1 (Appendix 16.2), subjects have at least one measurable lesion that has not been locally treated [receivable lesions with clear disease progression after topical treatment; no bone metastases are accepted as measurable Lesion; 6) At the dose climbing stage, patients with ALK-positive non-small cell lung cancer diagnosed by histology or cytology were enrolled in the ALK-positive non-small cell lung cancer patients treated with one or two ALK inhibitors at the dose expansion stage. Pathology report requirements: Accept ALK positive reports from previous FISH, Ventana IHC and RT-PCR, and provide organizations with ALK retests whenever possible; If there is no previous report, the organization must be provided for ALK FISH, Ventana IHC or RT-PCR detection; 7) Patients with brain metastases who have no brain metastases, or who are asymptomatic and do not require clinical intervention, or patients with brain metastases that have been stable for more than 4 weeks after treatment; 8) The patient must have adequate organ function (supportive care that does not affect the following results within 14 days prior to testing), as defined below: liver function: No liver metastasis, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT) and glutamyltransferase (GGT) =1.5x10^9/L; Platelet (PLT) >=100x10^9/L; Hemoglobin (Hb) >=90 g/L. Kidney function: Creatinine clearance >=60 mL/min Pancreas function: Total serum amylase =50%. 9) Any previous toxicity associated with anti-tumor treatment must have been restored to <=1 (except for hair loss); 10) All women of childbearing age must have a negative pregnancy test and male and female patients with fertility must agree to remain abstinence or use contraception for at least 3 months after the entire study period and the last use of the test drug (see appendix for details). 16.4); 11) The patient agrees and is able to follow the trial and follow-up procedure and sign the informed consent form in writing.
Exclusion criteria
Exclusion criteria: Patients with any of the following items cannot be enrolled in the study: 1) Patients within 3 months prior to the first dose: cerebrovascular accident/stroke, myocardial infarction, severe/unstable angina, congestive heart failure (New York Heart Association classification >= II), second or third Atrioventricular block (unless there is a pacemaker) or any atrioventricular block with a PR interval >220 msec; or any level of uncontrolled atrial fibrillation; 2) ECG examination revealed QTcF men > 450 msec, women > 470 msec, or congenital long QT syndrome; 3) >=3 peripheral neuropathy (CTCAE version 5.0); 4) The history of any active autoimmune disease or autoimmune disease requires long-term use of steroid hormones or other immunosuppressive agents; 5) History of previous interstitial lung disease, history of drug-induced interstitial lung disease, history of radiation pneumonitis requiring steroid therapy, or any indication of clinically active interstitial lung disease; 6) gastrointestinal dysfunction or gastrointestinal diseases that may affect drug absorption (eg, CTCAE >= 2 ulcerative disease, uncontrollable nausea, vomiting, diarrhea or adverse absorption syndrome); 7) Patients receiving any anticoagulant therapy, bleeding tendency or coagulopathy; 8) Active hepatitis (hepatitis B: HBcAb positive and HBV-DNA >= 1000 IU/ml; hepatitis C: HCV antibody positive and HCV-RNA >= 1000 IU/ml), HIV antibody positive; syphilis spiral antibody positive; 9) Patients who underwent major surgery within 4 weeks prior to the first dose; 10) Radical therapy was given within 4 weeks prior to the first dose, or palliative radiotherapy was given within 2 weeks prior to the first dose, or radiopharmaceutical was received within 8 weeks prior to the first dose (strontium, Samarium Patient); 11) Received systemic anti-tumor therapy within 4 weeks prior to the first dose (targeted therapy for 2 weeks), including chemotherapy, immunotherapy, biotherapy (tumor vaccine, cytokine or growth factor controlling cancer) and adaptation a patient with a clear anti-tumor Chinese medicine; 12) Patients who are treated with the following drugs and cannot be discontinued at least 7 days prior to the first dose and discontinued during the study period: drugs known to be strong inducers or strong inhibitors of CYP3A (see the combined use prohibited by this study) ; 13) Any patient with active infection requiring systemic systemic therapy within 4 weeks prior to the first dose; 14) According to the investigator's judgment, there are serious accompanying diseases (such as severe diabetes) that are harmful to the patient's safety or affect the patient's completion of the study; 15) There is a clear history of neurological or psychiatric disorders, including dementia or epilepsy diagnosed for any reason; 16) There are other history of malignant tumors (except for basal cell skin cancer and cervical carcinoma in situ); 17) According to the investigator's judgment, it may increase the risk associated with the study, may interfere with the interpretation of the results of the study, or patients considered by the investigator to be unsuitable for inclusion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| PK parameters;ORR;DCR;DOR;PFS; | — |
Primary
| Measure | Time frame |
|---|---|
| Safety tolerance;DLT and MTD;RP2D; | — |
Countries
China
Contacts
Public ContactDechuang Yuan
Shouyao Holdings(Beijing)Co.Ltd.
Outcome results
None listed