Status:
UNKNOWN
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 table...
Eligibility Criteria
Inclusion
- 1\. Histologically or cytologically confirmed advanced malignant solid tumors, without conventional treatment methods or fail or relapse after treatment.
- 2\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- 3\. Has at least one measurable lesion (based on RECIST 1.1) or bone metastases. 4. Adequate organ system function. 5. Patients need to adopt effective methods of contraception. 6. Understood and signed an informed consent form.
Exclusion
- 1\. Has received TRK inhibitors. 2. Has participated in any other clinical trials, or used other anti-cancer drugs, or received major surgical operations within 4 weeks before first administration.
- 3\. Has received local radiotherapy within 7 days or bone marrow radiotherapy within 4 weeks before the first administration.
- 4\. Has other malignant tumors in 2 years, except for cured or locally curable cancers.
- 5\. Has known spinal cord compression and cancerous meningitis. 6. Has interstitial lung disease, drug-induced interstitial lung disease, history of radiation lung disease requiring steroid therapy.
- 7\. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- 8\. Obvious cardiovascular diseases. 9. Has a history of autoimmune disease, immunodeficiency. 10. Lactating women. 11. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04408079
Start Date
June 25 2020
End Date
October 31 2022
Last Update
July 8 2020
Active Locations (1)
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1
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233