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.
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.
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).
Single group
BR113 for injection
DrugDosage 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
DLT（Phase 1a）
Occurrence of dose-limiting toxicity (DLT)
Treatment-emergent adverse events (Phase 1a)
CTCAE≥Grade 3 TEAE, serious TEAE, TEAE leading to drug suspension/discontinuation, et al.
RP2D (Phase 1b)
Recommended Phase II dose (RP2D).
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.
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).
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) after single and multiple dose of BR113
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
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This trial is not recruiting at the moment. You can still explore other options:
