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).