Status:
COMPLETED
The Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is an open-label, phase I clinical trial of SHR-A2009 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expa...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
- Have at least one measurable tumor lesion per RECIST v1.1;
- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
- Adequate bone marrow and organ function.
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Exclusion
- Patients with active central nervous system metastases or meningeal metastases;
- Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
- History of serious cardiovascular and cerebrovascular diseases;
- Severe infection within 4 weeks prior to the first dose;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Key Trial Info
Start Date :
July 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05394818
Start Date
July 21 2022
End Date
April 30 2024
Last Update
December 27 2024
Active Locations (1)
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1
Chinese PLA General Hospital-Department of Medical Oncology
Beijing, Beijing Municipality, China, 100039