Actively Recruiting
A Study of CBP-1008 in Patients With Advanced Solid Tumor
Led by Coherent Biopharma (Suzhou) Co., Ltd. · Updated on 2024-08-28
143
Participants Needed
3
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1008, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of CBP-1008 in Patients With Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years at consent
- Life expectancy of at least 3 months
- For phase Ia: advanced malignant solid tumor progressed on or intolerant to standard therapy, or no standard therapy exists
- For phase Ib: specific tumor cohorts including platinum-resistant ovarian cancer, metastatic triple-negative breast cancer, and other advanced solid tumors
- Eastern Cooperative Oncology Group performance status of 0 or 1
- At least one measurable tumor lesion as per RECIST v1.1
- Availability of archived or fresh tumor tissue samples
- Positive test for FOLR1 and/or TRPV6 receptor expression
- At least 28 days since last anti-tumor therapy before starting CBP-1008
- Previous treatment toxicities resolved to grade 0 or 1 per NCI-CTCAE 4.03
- Adequate blood cell counts without recent transfusion or growth factors
- Adequate liver function within specified laboratory limits
- Adequate kidney function with creatinine clearance ≥50 mL/min/1.73 m²
- Coagulation parameters within specified limits or therapeutic range if on anticoagulants
- Serum calcium concentration within defined range
- Adequate heart function with left ventricular ejection fraction ≥50% and QTc-F ≤450 ms
You will not qualify if you...
- Allergy to any component of CBP-1008
- Any other cancer within 3 years except certain treated cancers
- History of epilepsy
- Active or symptomatic brain metastases or cancerous meningitis except stable or asymptomatic brain metastases
- Severe heart conditions or medications prolonging QT interval
- Recent major surgery or ongoing complications within 21 days before first dose
- Radiotherapy within 21 days before first dose
- Interstitial lung disease, uncontrolled infections, or poorly controlled systemic diseases
- Clinically significant pericardial effusion, pleural effusion, or ascites needing drainage
- Peripheral neuropathy grade 2 or higher
- For lung squamous cell carcinoma, recent significant hemoptysis
- Recent gastrointestinal perforation or complete intestinal obstruction
- High bleeding or fistula risk from tumor invasion
- Use of strong/moderate CYP3A inhibitors or inducers within 10 days before first dose
- Pregnancy or breastfeeding
- Any condition increasing safety risk or limiting compliance
- Alcoholism within 3 months before first dose
- Known drug abuse within 6 months before consent
- HIV, active hepatitis B or C, or syphilis infection
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
J
Jiangang Yu
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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