Status:
UNKNOWN
A Study of TY-302 in Patients With Advanced Solid Tumors
Lead Sponsor:
TYK Medicines, Inc
Conditions:
Breast Cancer
Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of TY-302 single and the combination with Tamoxifen in dose-escalation and dose-expansion study.The drugs involved in thi...
Detailed Description
This is an open-label, single-arm, phase I trial. The purpose of this study is to : * Test a safe and tolerable dose of TY-302 single and the combination with Tamoxifen * Determine the response rate ...
Eligibility Criteria
Inclusion
- 18-70years old, male or female with solid tumors, female with breast cancer
- Histological or cytological confirmation diagnosis of advanced solid tumors (except small cell lung cancer and eye cancer) in TY-302 alone study; and advanced breast cancer in the combination study.
- Biopsy proven diagnosis of ER and/or PR positive, HER2 negative.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
- Life expectancy of at least 3 month.
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or AST and ALT ≤5 x ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin ≤1.5 x ULN; Absolute neutrophil count (ANC) ≥1.5×109/L; platelets(PLT)≥75×109/L ; Hemoglobin(Hb) ≥ 90g/L; Serum creatinine ≤1.5 x ULN; Left ejection fraction (LVEF)≥50%; QTc≤470 msec (based on the mean value of the triplicate ECGs).
- Female subjects have a negative urine or serum pregnancy.
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
Exclusion
- Subjects presenting with any of the following were not to be included in the study:
- Previously treated by other CDK4/6 inhibitor.
- Hypersensitivity to TY-302(or Tamoxifen in the combination study) or to any of its excipients.
- Ocular fundus diseases in the combination study.
- Uncontrolled intercurrent illness including active infection, human immunodeficiency virus infection, active hepatitis or other severe acute or chronic medical or psychiatric condition.
- Current alcohol/drug abuse or dependence.
- Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE grade≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure of NCI CTCAE grade≥2, cerebrovascular accident.
- Presence of a condition that would interfere with enteric absorption of TY-302 and/or Tamoxifen.
- Any cytotoxic chemotherapy, investigational agents or anticancer drugs for the treatment from a previous treatment regimen within 4 weeks of the first dose.
- Spinal cord compression or brain metastases unless asymptomatic.
- Major surgery within 8 weeks of first study treatment.
- Current use or anticipated need for drugs that are known strong CYP3A4 inhibitors, strong CYP3A4 inducers, Narrow therapeutic index for CYP3A sensitive substrates, CYP2D6 inhibitors, CYP2D6 inducers.
- Patients on chronic anticoagulation.
- The subject inappropriate for entry into this study in the judgment of the investigator.
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04433494
Start Date
December 7 2020
End Date
December 1 2023
Last Update
December 7 2022
Active Locations (1)
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1
Chinese Academy of Medical Sciences and Peking Union Medical Colledge
Beijing, Beijing Municipality, China, 100021