Actively Recruiting
A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer
Led by Biocity Biopharmaceutics Co., Ltd. · Updated on 2024-08-12
148
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Locally advanced or metastatic solid tumors confirmed by histology or cytology with known CDH3 expression or reasonable likelihood of benefit
- Agreement to provide archived or newly obtained tumor tissue samples
- At least one measurable tumor lesion as per RECIST 1.1 criteria
- Life expectancy of 3 months or longer
- Adequate organ function
- Use of highly effective contraception during the study and for 6 months after last dose for men or women of childbearing potential
- Voluntary participation with written informed consent
You will not qualify if you...
- Pregnant or lactating women
- Prior systemic anticancer treatment including investigational agents within 5 half-lives or 4 weeks before the first dose
- Diagnosed immunodeficiency within 7 days before first dose or on long-term immunosuppressive therapy
- Previous allogeneic tissue or solid organ transplantation
- Radiation therapy within 2 weeks before study treatment or history of radiation pneumonitis
- Active central nervous system metastases or cancerous meningitis (unless stable and off steroids for at least 14 days)
- Active viral infection requiring systemic therapy during screening
- Uncontrolled pericardial effusion, pleural effusion, or ascites at screening
- History or current pneumonitis or interstitial lung disease requiring steroids
- Hypertension not controlled to 150/90 mmHg or below
- Significant cardiovascular disease including certain heart failures, arrhythmias, recent heart attack, or major surgeries
- Active or chronic corneal disorders preventing drug monitoring
- Peripheral neuropathy grade 2 or higher or unresolved toxicities above grade 1 except alopecia or pigmentation
- Active infection requiring treatment
- Known hypersensitivity to BC3195 or its components
- Use of strong CYP3A4 inhibitors or inducers within 14 days before first dose
- Investigator judgment of unsuitability for study participation
- Poor compliance or unwillingness to follow study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
E
Eric Rowinsky, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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