Can a new drug shrink Hard-to-Treat tumors?
NCT ID NCT07753590
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 258 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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- Oral drug RVU120 put to the test against advanced solid tumors