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UnknownNCT04891653

A Phase I Study of BR790 in Subjects With Advanced Solid Tumors

A Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Efficacy of BR790 Monotherapy in Subjects With Advanced Solid Tumors

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
48 (estimated)
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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), maximum tolerated dose (MTD) and/or recommended phase II clinical trial dose (RP2D) .The study is divided into two phases: dose escalation phase and dose expansion phase.

Conditions

Interventions

TypeNameDescription
DRUGBR790Subjects will receive oral administration of BR790.

Timeline

Start date
2021-06-30
Primary completion
2023-06-30
Completion
2023-12-31
First posted
2021-05-18
Last updated
2021-05-18

Source: ClinicalTrials.gov record NCT04891653. Inclusion in this directory is not an endorsement.

A Phase I Study of BR790 in Subjects With Advanced Solid Tumors (NCT04891653) · Clinical Trials Directory