A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiocity Biopharmaceutics Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BC2027 for Injection

Treatment groups

180 Participants
are divided into 1 treatment group