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Phase I/IIa Study of BR790 in Combination With Tislelizumab in Adult Subjects With Advanced Solid Tumors

NCT05505877 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-08-18

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

BR790+Tislelizumab

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

Sponsors & Collaborators

  • Shanghai Gopherwood Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • li zhang · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-10
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05505877 on ClinicalTrials.gov