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Advanced Solid TumorsPhase 1NCT07753590

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

A Phase 1 study testing BR113 for injection in people with Advanced Solid Tumors, run by BioRay Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
BR113 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
258 participants
Where
No sites listed yet
Study dates
Aug 2026to Dec 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the Informed Consent Form (ICF), understand the nature, purpose, and procedures of the trial, and agree to complete the trial in accordance with the protocol.
  • Age ≥ 18 years (as of the date of ICF signing), with no restriction on gender.
  • Have histologically and/or cytologically confirmed unresectable, advanced/metastatic solid tumor that is refractory to standard therapy (disease progression or recurrence during or after treatment), intolerant to standard therapy, or for whom no available standard therapy exists.
  • Have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Echocardiogram (ECHO) performed within 28 days prior to the first dose shows left ventricular ejection fraction (LVEF) ≥ 50%.
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  • Adverse events related to prior anti-tumor therapy have recovered to Grade 0-1 per Common Terminology Criteria for Adverse Events (CTCAE),.
  • Adequate bone marrow function within 14 days prior to the first dose.
  • Adequate organ function within 14 days prior to the first dose.
  • Sufficient washout period from prior therapy before the first dose.
  • Expected survival ≥ 12 weeks.
  • Study participants must provide archival tumor resection specimens (preferably collected within 2 years) or receive tumor tissue biopsy.
  • Female participants of childbearing potential (WOCBP) must have a negative serum human chorionic gonadotropin (HCG) test at study entry (within 72 hours before the first dose), and agree to practice true abstinence or use highly effective contraception from the date of signing the ICF until 6 months after the last dose of study treatment. They must not donate germ cells for assisted reproductive purposes during this period.
  • Male participants must voluntarily practice abstinence or use highly effective contraception from the date of signing the ICF until 6 months after the last dose, and must not donate sperm for assisted reproductive purposes during this period.

Who cannot join

  • History of hypersensitivity to any component or excipient of BR113 Injection.
  • Prior therapy with Trop-2-targeted agents (including antibodies or ADCs), exatecan, or ADC drugs with exatecan as the payload.
  • Prior therapy with STING pathway agents (including STING agonists and STING inhibitors).
  • Active infection requiring systemic therapy within 2 weeks prior to the first dose; excluding patients receiving short-term antibiotic prophylaxis (e.g., for urinary tract infection or exacerbation of chronic obstructive pulmonary disease).
  • Unstable pleural effusion or ascites requiring thoracentesis or paracentesis within 2 weeks prior to the first dose.
  • Major organ surgery within 4 weeks prior to the first dose, or elective surgery planned during the trial.
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  • Vaccination with live attenuated vaccine within 4 weeks prior to the first dose.
  • History of other primary malignant tumors (excluding the study disease) within 5 years prior to enrollment; excluding curatively resected non-melanoma skin cancer (e.g., basal or squamous cell carcinoma) and curatively resected carcinoma in situ (e.g., cervical or breast carcinoma in situ).
  • Uncontrolled or severe cardiovascular/cerebrovascular disease.
  • Severe pulmonary disease.
  • History of severe hematological toxicity during prior systemic therapy (e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3-4 neutropenia).
  • Active CNS metastases (defined as symptomatic CNS metastases without anti-tumor therapy [e.g., radiotherapy] or requiring corticosteroid/anticonvulsant therapy).
  • Active gastrointestinal bleeding or intestinal obstruction.
  • Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Poorly controlled diabetes mellitus or history of diabetic ketoacidosis.
  • Thromboembolism requiring anticoagulant therapy diagnosed within 6 months prior to enrollment, or known hereditary or acquired bleeding diathesis (e.g., hemophilia, coagulation disorder); excluding low-dose prophylactic anticoagulation (e.g., low-molecular-weight heparin).
  • Active keratitis or conjunctivitis.
  • Systemic corticosteroid therapy for > 1 week within 2 weeks prior to the first dose (methylprednisolone > 10 mg/day or equivalent dose of other similar drugs).
  • Use of immunosuppressants within 2 weeks prior to the first dose, active autoimmune disease, or history of autoimmune disease.
  • Human Immunodeficiency Virus (HIV) infection (seropositive) or Acquired Immunodeficiency Syndrome (AIDS).
  • Positive non-specific syphilis antibody test (e.g., TRUST, PRP) or positive specific syphilis antibody test (e.g., TPPA).
  • Active tuberculosis or anti-tuberculosis treatment within 1 year prior to enrollment.
  • HBsAg-positive with HBV-DNA > 1000 IU/mL.
  • HBcAb-positive with HCV-RNA above the study site's lower limit of detection.
  • Any psychiatric or cognitive disorder that may limit understanding or execution of the ICF.
  • Pregnant or lactating females (excluding females who voluntarily discontinue breastfeeding).
  • Participants deemed ineligible for enrollment by the investigator or unable to complete the trial for other reasons.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jian Zhang contact

(+86)021-64175590-81807

syner2000@163.com

About this study

Official title: A Multicenter, Open-label, Two-stage Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BR113 in Patients With Advanced Solid Tumors

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.

Being tested
BR113 for injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BR113 for injectionDrug

    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 groups in NCT07753590
Study groupRoleWhat they receive
BR113ExperimentalNot described
Receives: Drug: BR113 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT（Phase 1a）

    Occurrence of dose-limiting toxicity (DLT)

    Measured: up to 21 days after first dose of BR113

  2. Treatment-emergent adverse events (Phase 1a)

    CTCAE≥Grade 3 TEAE, serious TEAE, TEAE leading to drug suspension/discontinuation, et al.

    Measured: Baseline through study completion (30 days after last dose), up to approximately 20 months.

  3. RP2D (Phase 1b)

    Recommended Phase II dose (RP2D).

    Measured: Through study completion, approximately 3 years.

Secondary outcomes (6)

  1. Objective response rate (ORR)

    Objective response rate (ORR) is defined as the percentage of patients with a complete response (CR) or partial response (PR) that was confirmed at a subsequent scan at least 4 weeks later, as assessed according to RECIST version 1.1.

    Measured: Up to approximately 3 years

  2. Progression-free survival (PFS)

    Progression-free survival (PFS) is defined from the first dose to the first documented disease progression or death due to any cause (whichever occurs first).

    Measured: Up to approximately 3 years

  3. Peak Plasma Concentration (Cmax)

    Peak Plasma Concentration (Cmax) after single and multiple dose of BR113

    Measured: Up to approximately 3 years

  4. Area under the plasma concentration versus time curve (AUC)

    Area under the plasma concentration versus time curve (AUC) after single and multiple dose of BR113

    Measured: Up to approximately 3 years

  5. Terminal half-life (T1/2)

    Terminal half-life (T1/2) after single dose of BR113

    Measured: Up to approximately 3 years

  6. The anti-drug antibody (ADA) of BR113

    Detection of anti-drug antibodies (ADA) to BR113 in blood; patients with positive ADA will be further evaluated for antibody titer and neutralizing antibodies (NAb).

    Measured: Baseline through study completion(30 days after last dose)，Up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionFeb 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
258 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753590
Sponsor's protocol ID
BR113-CR-101
Status last verified
Jul 2026
First submitted
29 Jul 2026
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BR113 for injection in people with Advanced Solid Tumors, run by BioRay Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jian Zhang ((+86)021-64175590-81807, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT（Phase 1a） (time frame: up to 21 days after first dose of BR113). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07753590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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