A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Biocity Biopharmaceutics Co., Ltd.
Study ID
NCT06548672
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BC3195 — DRUG
    BC3195 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).

Study Details

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.

Key Dates

Start date
Jun 24, 2024
Status verified
Aug 2024
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
148 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Phase 1a Dose Escalation
    Participants will receive BC3195 administered as an intravenous infusion every 3 weeks (Q3W) or according to an alternative dosing regimen, as recommended by the safety monitoring committee (SMC). Multiple dose cohorts will be enrolled. Participants will be monitored for dose limiting toxicities (DLTs) during the DLT assessment period, lasting 21 days. The SMC will determine the recommended phase 2 dose (RP2D) to be administered in Part 2 based on the safety, tolerability, PK, and anti-tumor activity of BC3195
  • Experimental: Part 2: Phase 1b Dose Expansion
    Participants will receive BC3195 at the RP2D identified in Phase 1a. Approximately 3 to 4 expansion cohorts will be enrolled using a Simon's 2-stage design. Expansion cohorts will focus on tumor types that may derive benefit from BC3195 treatment, including head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), breast cancer (BC), non-small cell lung cancer (NSCLC), endometrial cancer (EMC), urothelial cancer (UC), colorectal cancer (CRC), ovarian cancer (OC), pancreatic cancer, and prostate cancer.

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: First 21 days of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Case Western Reserve UniversityClevelandOhio44106
Giselle Dutcher, MD
[email protected]

Find similar trials in Cleveland, OH

By research site
Case Western Reserve University· Cleveland, OH

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