Actively Recruiting
A Study of CBP-1018 in Patients With Advanced Solid Tumors
Led by Coherent Biopharma (Suzhou) Co., Ltd. · Updated on 2024-08-28
170
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, non-randomized, multi-center, phase I study of bi-ligand-drug conjugate CBP-1018 in patients with advanced solid tumors. This study will be conducted in 2 parts: Part A (Dose Escalation) and Part B (Dose Expansion). Both parts include screening period, treatment period, end of treatment (EOT)/withdrawal, safety follow-up (SFU) and long-term-follow-up (LTFU). CBP-1018 will be administrated on eligible subjects until disease progression, unacceptable toxicity, withdrawal of consent or Sponsor's decision to stop the study, etc.
CONDITIONS
Official Title
A Study of CBP-1018 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of informed consent before any study procedures
- Men or women aged 18 years or older at consent
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months as judged by the investigator
- Pathologically confirmed advanced solid tumor including metastatic castration resistant prostate cancer, advanced renal cell cancer, or advanced lung squamous cell cancer
- Prior standard therapy received or unlikely to benefit from standard care
- At least one measurable lesion not previously irradiated (optional for low dose in Part A)
- Available archived or fresh tumor tissue samples (optional for low dose in Part A)
- Adequate bone marrow and organ function as defined by specific blood counts and liver and kidney function tests
- Left ventricular ejection fraction (LVEF) of 50% or higher by echocardiography or MUGA
- Negative pregnancy test for females of childbearing potential within 72 hours before first dose
- Agreement to use effective contraception during the study and for 30 days after last dose for males and females of reproductive potential
You will not qualify if you...
- Known allergy or hypersensitivity to study drug or its components
- Another active cancer within 5 years except certain treated cancers
- Active central nervous system metastases unless treated and stable
- Major surgery, anticancer therapy, or participation in other studies within 4 weeks before first dose
- Radiotherapy within 21 days before first dose or palliative radiotherapy within 7 days
- Unresolved severe side effects from prior anticancer therapy
- Poorly controlled diseases like diabetes or high blood pressure above specified limits
- Recent serious cardiovascular events within 12 months
- Significant lung diseases or suspected lung conditions
- Active bleeding disorders or recent severe hemorrhage
- Need for oral vitamin K antagonist anticoagulation (except low-dose for specific uses)
- Recent history of deep vein thrombosis or pulmonary embolism within 6 months
- Active infection requiring IV antibiotics within 1 week
- Known HIV/AIDS or certain hepatitis infections
- Live-virus vaccination within 30 days before first dose
- Current or planned treatment with strong CYP3A4 inhibitors or inducers
- Any other condition or abnormality that may interfere with study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen memorial hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510288
Not Yet Recruiting
2
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
J
Jiangang Yu, Ph D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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