Status:
UNKNOWN
A Phase I Study of BR790 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of the study was to evaluate the safety and tolerability of BR790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (DLT), maxi...
Eligibility Criteria
Inclusion
- Sign informed consent voluntarily.
- Age ≥18 and ≤75 years old.
- Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment.
- Had at least one measurable lesion.
- ECOG≤1.
- Expected survival period ≥ 3 months.
Exclusion
- Any previous treatment with SHP-2 inhibitor.
- Symptomatic brain metastases.
- Subjects with thoracic/ascites fluid that need drainage or intervention.
- Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<90g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases), Cr \>1.5×ULN.
- With uncontrolled severe disease.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04891653
Start Date
June 30 2021
End Date
December 31 2023
Last Update
May 18 2021
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