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A Study of BR101 Injection Alone in Subjects With Advanced Solid Tumors

NCT06001580 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-11-21

No results posted yet for this study

Summary

This study is a phase Ia study of single drug BR101 for Advanced solid tumor. The main purpose of this study is to Evaluate the safety and tolerability of BR101monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors and determine the MTD if possible, and determine the RP2D.

The secondary purpose of this study is to explore the Pharmacokinetics, Immunogenicity, Antitumor Activity of BR101 monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

BR101

BR101 injection was administered once for 28 days observation period and then weekly until the subject experienced unacceptable toxicity, disease progression, poor compliance, pregnancy, informed withdrawal, death, study interruption, and withdrawal from the study

Sponsors & Collaborators

  • BioRay Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-11
Primary Completion
2023-10-27
Completion
2024-02-07

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 NCT06001580 on ClinicalTrials.gov