CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 160 target
Drug / intervention
BR790+Tislelizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05505877
NCT05505877Phase 2Unknown

A Multicenter, Open-Label Phase 1/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Efficacy of BR790 Tablets in Combination With Tislelizumab Injection in Patients With Advanced Solid Tumors

Shanghai Gopherwood Biotech Co., Ltd.·interventional·Posted Aug 18, 2022·Updated Aug 18, 2022

In Brief

A Phase 2 clinical trial evaluating BR790+Tislelizumab for Advanced Solid Tumor. Targeting 160 participants across 1 site.

Detailed Summary

This study is a Phase I/IIa, multi-center, open-label study of BR790 in combination with Tislelizumab with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors. These treatment to characterize the safety, tolerability, PK, PD and preliminary antitumor activity. The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2UnknownOverdue
2023202420252026
First PostedAug 18, 2022
Enrollment StartSep 10, 2022
Primary CompletionOct 31, 2024
Study CompletionDec 31, 2024
TodayJul 1, 2026
Enrollment to primary: 2.1 yearsPosted 3.9 years ago

Interventions

BR790+Tislelizumabdrug

BR790 will be administered orally, variable dose. Tislelizumab will be administered as an intravenous infusion,fixed dose.