A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer
NCT Number: NCT06548672
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Cancer|Metastatic Solid Tumor
Interventions: DRUG: BC3195
Sponsor: Biocity Biopharmaceutics Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 148
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2027-06-30
Locations: Case Western Reserve University, Cleveland, Ohio, 44106, United States

Summary:
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.

Primary Outcome Measures: Incidence of Dose Limiting Toxicities (DLTs), First 21 days of treatment|Determination of the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), Day 1 of treatment through 30 days after the last dose|Incidence and Severity of All Adverse Events (AEs), Screening through 12 weeks after the last dose
Secondary Outcome Measures: Objective Response Rate (ORR), Assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1, Day 1 of treatment through 6 weeks after the last dose|Disease Control Rate (DCR), Proportion of subjects with CR, PR, and stable disease (SD), Day 1 of treatment through 6 weeks after the last dose|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, Day 1 of treatment through 6 weeks after the last dose|Time to Progression (TTP), Defined as the length of time from the start of treatment until first evidence of disease progression, Day 1 of treatment through 6 weeks after the last dose|Progression Free Survival (PFS), Defined as the time from which the subject is enrolled to the date of any recorded disease progression or the death of any cause, Day 1 of treatment through 6 weeks after the last dose|Overall Survival (OS), Defined as the time from Day 1 of dosing until the date of death from any cause assessed up to 100 months, Patient consent until death Day 1 of dosing until the date of death from any cause assessed up to 100 months|Area under the curve (AUC) of BC3195, Area under the BC3195 time vs concentration curve, Day 1 of dosing through 21 days post last dose|Maximum concentration (Cmax) of BC3195, Maximum concentration observed following dosing, Day 1 of dosing through 21 days post last dose|Time to reach maximum concentration (Tmax) of BC3195, Time at which the maximum concentration of BC3195 is observed, Day 1 of dosing through 21 days post last dose|Half-life (t 1/2) of BC3195, Time at which BC3195 concentration is reduced by one half, Day 1 of dosing through 21 days post last dose|Volume of distribution (Vd) of BC3195, Volume of distribution, Day 1 of dosing through 21 days post last dose|Clearance (CL) of BC3195, Volume of drug cleared in a period of time, Day 1 of dosing through 21 days post last dose|Immunogenicity indicators, Anti-drug antibody (ADA), Day 1 of dosing through 30 days post last dose