Status:
UNKNOWN
A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced No...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years old;
- Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
- For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
- Measurable or evaluable disease;
- Adequate bone marrow, liver, and renal function.
Exclusion
- Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators;
- Pregnancy or lactation;
- Other protocol specified criteria.
Key Trial Info
Start Date :
July 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05329298
Start Date
July 21 2021
End Date
December 31 2023
Last Update
April 15 2022
Active Locations (8)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
2
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
3
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
4
Hunan cancer hospital
Changsha, Hunan, China, 410013