> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-to-evaluate-single-agent-therapy-of-br113-832d5dbb-8729-48b8-8d40-9b401c503120 > Record changed: 2026-10-13 # A Clinical Study to Evaluate Single-agent Therapy of BR113 for Injection in Patients With Advanced Solid Tumors NCT07753590 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) Participants 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) Lead sponsor BioRay Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) Start date 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Short title** A Clinical Study to Evaluate Single-agent Therapy of BR113 for Injection in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Dates **Completion date** 2030-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **First posted** 2026-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Registry last updated** 2026-08-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Primary completion date** 2030-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Start date** 2026-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Size and sites **Participants** 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Planned participants** 258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Lead sponsor** BioRay Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Identifiers **Registry ID** NCT07753590 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **ClinicalTrials.gov ID** NCT07753590 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Outcomes ### Primary outcomes 1. DLT（Phase 1a） Timeframe: up to 21 days after first dose of BR113 Occurrence of dose-limiting toxicity (DLT) 2. Treatment-emergent adverse events (Phase 1a) Timeframe: Baseline through study completion (30 days after last dose), up to approximately 20 months. CTCAE≥Grade 3 TEAE, serious TEAE, TEAE leading to drug suspension/discontinuation, et al. 3. RP2D (Phase 1b) Timeframe: Through study completion, approximately 3 years. Recommended Phase II dose (RP2D). ### Secondary outcomes 1. Objective response rate (ORR) Timeframe: Up to approximately 3 years 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. 2. Progression-free survival (PFS) Timeframe: Up to approximately 3 years 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). 3. Peak Plasma Concentration (Cmax) Timeframe: Up to approximately 3 years Peak Plasma Concentration (Cmax) after single and multiple dose of BR113 4. Area under the plasma concentration versus time curve (AUC) Timeframe: Up to approximately 3 years Area under the plasma concentration versus time curve (AUC) after single and multiple dose of BR113 5. Terminal half-life (T1/2) Timeframe: Up to approximately 3 years Terminal half-life (T1/2) after single dose of BR113 6. The anti-drug antibody (ADA) of BR113 Timeframe: Baseline through study completion(30 days after last dose)，Up to approximately 3 years 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). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07753590) ## Related records ### Drugs (1) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) ### Lead sponsors (1) - [BioRay Pharmaceutical Co., Ltd.](https://trialight.com/data/company/bioray-pharmaceutical-co-ltd-8d66440f-ca6d-4397-88e7-b2b1ae5007c0.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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