A Clinical Study to Evaluate Single-agent Therapy of BR113 for Injection in Patients With Advanced Solid Tumors

Sponsor
BioRay Pharmaceutical Co., Ltd.
Study ID
NCT07753590
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BR113 for injection — DRUG
    Dosage and Administration: BR113 for Injection is administered intravenously as monotherapy . Treatment shall continue until the occurrence of intolerable toxicity, disease progression, death, or subject withdrawal from study treatment

Study Details

This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR113 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR113 for injection in patients with advanced malignancies.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
258 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BR113

Primary Outcome Measure

DLT（Phase 1a） [ Time Frame: up to 21 days after first dose of BR113 ]

Central Contacts

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