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Can a new drug shrink Hard-to-Treat tumors?

NCT ID NCT07753590

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This early-stage trial is testing an investigational drug called BR113 in people with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the right dose, and see if it can shrink tumors. Participants receive BR113 intravenously and are monitored for side effects and how their cancer responds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BR113 for injection
What this could lead to
If BR113 proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase, first-in-human study, so the drug may not work as hoped or may cause unexpected side effects. The results will need confirmation in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 258 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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%. * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.