Advanced Solid Tumor
Conditions
Interventions
None listed
Sponsors
Chinese Academy of Medical Sciences Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged from 18 to 65 years; 2) Subjects with locally advanced or metastatic malignant solid tumors diagnosed by histology or cytology and who have failed standard treatments (disease progression or intolerance) or lack standard treatments; advanced breast cancers with HR+/Her2- are preferentially included , Subjects with advanced colorectal cancer, advanced esophageal cancer or advanced gastric cancer; 3) ECOG performance status (PS) 0-1; 4) Estimated survival time >= 3 months; 5) According to the RECIST 1.1 standard, there are evaluable lesions; 6) Good organ function level (not receiving blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF), etc. within 14 days before study drug administration): ANC >= 2.0 x 10^9/L PLT >= 100 x 10^9/L Hb >= 110 g/L TBIL = 50% Fridericia method to correct QT interval (QTcF) male < 450 ms, female < 470 ms. 7) According to the judgment of the investigator, it can comply with the test protocol; 8) Volunteer to participate in this clinical trial, understand the research procedures and be able to sign written informed consent.
Exclusion criteria
Exclusion criteria: 1) Previous or current administration of any kind of CDK4/6 inhibitors; 2) The patient has received the following treatments within 7 days before entering the study: drugs known to be potent inhibitors/inducers of CYP3A4; drugs known to significantly prolong the QT interval; 3) Any other anti-tumor treatment (including cytotoxic chemotherapy, molecular targeted therapy, immunotherapy or other biological treatments) received within 4 weeks before taking the study drug for the first time, and within 6 weeks for mitomycin or nitrosamines , Small molecule targeted drugs are at least 2 weeks away from the last administration or at least 5 half-lives (whichever is longer), endocrine therapy is allowed, but endocrine therapy must be stopped when the informed consent is signed); 4) Participate in the clinical trial as a subject within 4 weeks before participating in this trial; 5) Brain metastases with clinical symptoms, or other evidence that the patient's brain metastases have not been controlled, and are not suitable for inclusion in the group as judged by the investigator; 6) There is a CTCAE >= grade 2 toxicity caused by previous treatment (except for grade 2 hair loss); 7) There is a third space effusion that cannot be controlled by drainage or other methods (such as a large amount of pleural fluid and ascites); 8) Long-term use of steroid therapy is required (except for those with a daily dose of = 104 copies/mL, HCV RNA test positive); 13) A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 14) Have ever suffered from any heart disease, including but not limited to: a. Unstable angina pectoris; b. Arrhythmia requiring medication or clinical significance; c. Myocardial infarction within 6 months; d. Heart failure; e. The New York Heart Association (NYHA) Heart Function Grade >= Grade II; f. Any other heart diseases judged by the investigator as unsuitable for participating in this trial; 15) Pregnancy, breastfeeding women or women with childbearing potential have a positive blood pregnancy test during the screening period; 16) Male subjects and female subjects of childbearing age who are unwilling to take effective contraceptive measures within 6 months after signing the informed consent form until the last dose; 17) According to the judgment of the investigator, there are accompanying diseases (such as severe hypertension, diabetes, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the completion of the study; 18) Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance;Pharmacokinetics;RP2D; | — |
Countries
China
Contacts
Public ContactFei Ma
Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed