Suspended

BR115 Injection for Advanced Solid Malignancies

Study Aim

This study aims to evaluate the safety and tolerability of the BR115 injection in adults with advanced solid tumors by monitoring any adverse effects that occur after treatment.

What is being tested

BR115 for injection

Drug

Who is being recruted

Over 18 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: February 2024

See protocol details

Summary

Principal SponsorBioRay Pharmaceutical Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 19, 2024

Actual date on which the first participant was enrolled.

This clinical study is exploring a new treatment called BR115, which is given as an injection, for people with advanced solid tumors. These types of cancers have spread and are challenging to treat with existing options. The study aims to understand how safe and tolerable BR115 is, while also assessing its ability to fight cancer and its interaction with the body's immune system. This research is crucial as it might offer a new hope for patients with limited treatment options, potentially improving their quality of life and treatment outcomes. Participants in this study will receive BR115 injections, initially twice in the first week, and then once a week thereafter. The treatment will continue unless it causes serious side effects, the cancer worsens, or other specific conditions occur. Researchers will closely monitor participants to evaluate how their bodies process the drug, its effectiveness against tumors, and any immune responses triggered by the treatment. By gathering this information, the study aims to ensure the treatment is safe and understand how well it works in combating advanced cancers.

Official TitleA Phase I Clinical Study of the Safety, Tolerability and Efficacy of BR115 for Injection in Patients With Advanced Solid Malignancies

NCT06388902

Principal SponsorBioRay Pharmaceutical Co., Ltd.

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate

(8) Female subjects with fertility potential must test negative for serum human chorionic gonadotropin (HCG) before they are enrolled in the study. Female subjects with fertility potential or male subjects who have a female partner must agree to maintain no pregnancy plan and take effective contraceptive measures such as condoms from the signing of ICF to 6 months after the last dose of study drug; females are considered fertile from menarche to menopause (at least 12 months without menstruation) unless they are permanently infertile (through hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).

(3) In Phase Ia: patients must have advanced solid tumors confirmed by histopathology and/or cytology, the expression of HER2 was confirmed by the laboratory（IHC3+、or IHC2+ and FISH+、or IHC2+ and ISH-、or IHC1+）who have failed to respond to standard-of-care (disease progression after treatment) or who could not tolerate standard-of-care, or who could not obtain effective standard-of-care or for whom there was no effective standard-of-care available; (Note: the patient population and inclusion criteria in phase Ib will be determined according to the data of phase Ia);

(1) Subjects who voluntarily sign the informed consent form, understand the nature, objectives, and procedure of the study and are able to complete the study according to the protocol;

(2) ≥18 years of age (based on the date of signing the informed consent form);

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18 exclusion criteria prevent from participating

(13) Subjects who have been vaccinated with a live vaccine within 4 weeks before the first dose, or who intend to be vaccinated with a live vaccine during the study;

(15) Subjects who have used immunosuppressants within 2 weeks prior to the first dose or once had active autoimmune diseases or had a prior history of autoimmune diseases;

(7) Subjects who have undergone major surgery within 4 weeks prior to the first dose of study drug or are expected to be performed during the study;

(10) Systemic immunosuppressants/agonists (drugs with longer half-lives) , such as PD1, CTLA4,41BB, were used within 4 half-lives before the first administration;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sun Yat-sen University Cancer Center

Guangzhou, ChinaOpen Sun Yat-sen University Cancer Center in Google Maps

SuspendedOne Study Center