Actively Recruiting
A Phase 1 Study of CX1003 (Kanitinib) in Patients with Advanced Solid Tumors
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-10-17
126
Participants Needed
1
Research Sites
292 weeks
Total Duration
On this page
Sponsors
B
Beijing Konruns Pharmaceutical Co., Ltd.
Lead Sponsor
C
Chinese Academy of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
CX1003 is a novel multi-target tyrosine kinase inhibitor that is designed to primarily inhibit vascular endothelial growth factor receptor 2 (VEGFR2) and hepatocyte growth factor receptor (HGFR/MET). This study aimed to evaluate the safety, pharmacokinetics, and antitumor activity of CX1003 in patients with refractory advanced or metastatic solid tumors.
CONDITIONS
Official Title
A Phase 1 Study of CX1003 (Kanitinib) in Patients with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed recurrent or metastatic solid tumors
- At least one measurable lesion by RECIST 1.1 criteria
- Disease progression after or intolerance to prior standard therapy, or progression within 24 weeks after prior adjuvant/neoadjuvant therapy
- ECOG performance status of 0 or 1
- Expected overall survival of at least 12 weeks
You will not qualify if you...
- Untreated brain metastases or brain metastases symptoms uncontrolled for more than 4 weeks
- Other malignancies except certain early-stage or fully remitted cancers
- Blood and liver function abnormalities beyond specified limits
- History of primary hepatocellular carcinoma or severe liver cirrhosis
- Serum creatinine above 1.5 times upper normal limit or previous nephrotic syndrome
- Coagulation abnormalities or current use of certain blood-thinning medications except low-dose aspirin for prophylaxis
- Gastrointestinal diseases affecting oral drug intake or recent significant bleeding
- Serious cardiovascular or cerebrovascular diseases within specified time frames
- Unresolved toxicities from prior anticancer therapy except alopecia
- Participation in other clinical trials within 30 days
- Recent major surgery or significant trauma within 30 days
- History of organ transplant
- Need for systemic immunosuppressive therapy
- Uncontrolled infections
- HIV infection or active hepatitis B or C requiring treatment
- Pregnancy, lactation, or lack of contraception
- Mental or neurological disorders
- Other metabolic dysfunctions or abnormal clinical findings
- Inability to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
J
Junyu Wu, 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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