This is a phase Ia/Ib, open-label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, and preliminary anticancer activity of BC2027 in patients with advanced solid Malignanciesr
Provide written informed consent.
Be at least 18 years old.
Have an Eastern Cooperative Group (ECOG) performance status (PS) of 0 or 1.
Have a life-expectancy of at least 3 months based on the Investigator's assessment.
Prior treatment with GPC3-targeted ADC.
Prior treatment with systemic anticancer treatment, including investigational agents, within a period that is less than five half-lives or 2 weeks before the start of treatment, whichever is shorter.
Known hypersensitivity or delayed hypersensitivity reactions to the same class and/or any component of BC2027.
Treatment with strong CYP3A4 inhibitors or inducers, and P-gp inhibitors within 14 days or 5 half-lives whichever is shorter, before the first dose.
Single group
BC2027 for Injection
DrugDrug: BC2027 for Injection (lyophilized powder, 20 mg/vial) Administration: Administered via intravenous (IV) infusion, with dosing and frequency determined according to Phase Ia (dose escalation) and Phase Ib (dose expansion) study design.
Incidence of dose limiting toxicities (DLTs)
The incidence of dose-limiting toxicity (DLT) at different doses of BC2027 in patients with advanced solid malignancies
The safety and tolerability
To assess the safety and tolerability of BC2027 in patients with advanced solid malignancies
Preliminary antitumor activity
To assess the preliminary antitumor activity of BC2027 in patients with advanced solid malignancies
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