Status:
UNKNOWN
A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Malignant Neoplasms
Metastatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects w...
Eligibility Criteria
Inclusion
- Pathologically documented, locally-advanced or metastatic malignancy
- Standard treatment is not available or patient declines
- Adequate organ function
Exclusion
- Active brain metastases from non-brain tumors.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- Other protocol specified criteria
Key Trial Info
Start Date :
August 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05315180
Start Date
August 24 2021
End Date
July 31 2023
Last Update
April 7 2022
Active Locations (5)
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1
Shun Lu, Ph.D
Shanghai, Shanghai Municipality, China, 200030
2
Dingzhi Huang, Ph.D
Tianjin, Tianjin Municipality, China
3
Wen Li, Ph.D
Hangzhou, Zhejiang, China, 310009
4
Yun Fan,Ph.D
Hangzhou, Zhejiang, China, 310022