This is a phase Ia/Ib, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BC3195 in subjects with locally advanced or metastatic solid tumors in whom standard treatment has failed (either due to disease progression or intolerance). This study will consist of two parts: Dose escalation (Part 1) and dose expansion (Part 2). Each part will include a screening period, a treatment period, and follow-up period.
Male or female patients ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Subjects with locally advanced or metastatic solid tumors confirmed by histology or cytology who have not benefitted from or are intolerant of available therapy(ies) associated with a reasonable likelihood to confer clinical benefit because of known CDH3 expression, including, albeit not limited to: HNSCC, ESCC, BC, NSCLC, EC, UC, CRC, OC, pancreatic cancer, and prostate cancer.
Agree to provide previously archived tumor tissue samples, or newly obtained core biopsy, or excisional biopsy of a previously unirradiated tumor lesion (formalin fixed, paraffin embedded tissue blocks)
Pregnant or lactating women
Prior systemic anticancer treatment, including investigational agents, within 5 half-lives or 4 weeks before the first dose (whichever is shorter)
Subjects diagnosed with immunodeficiency within 7 days prior to the first dose of the study drug; or subjects who are receiving longterm systemic steroid therapy or any other form of immunosuppressive therapy
Previously received allogeneic tissue/solid organ transplantation
Sequential
BC3195
DrugBC3195 is a novel antibody drug conjugate (ADC) targeting CDH3 (calcium-dependent adhesion 3). The payload, monomethyl auristatin E (MMAE), is a microtubule disrupting agent covalently attached to the antibody via a cleavable dipeptide linker Val-Cit (vc).
Incidence of Dose Limiting Toxicities (DLTs)
Determination of the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)
Incidence and Severity of All Adverse Events (AEs)
Objective Response Rate (ORR)
Assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1
Disease Control Rate (DCR)
Proportion of subjects with CR, PR, and stable disease (SD)
Duration of Response (DoR)
Defined as the time from the date when the measurement criteria were met for complete or partial response (whichever occurred first) until the date of the first observed PD or death of any cause
Time to Progression (TTP)
Defined as the length of time from the start of treatment until first evidence of disease progression
Click on the lead sponsor to view all of their trials.
