NCT04093466 A Phase 1 Study of CX1003 (Kanitinib) in Patients with Advanced Solid Tumors
| NCT ID | NCT04093466 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Beijing Konruns Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2020-04-27 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 126 participants in total. It began in 2020-04-27 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed recurrent or metastatic solid tumors; * At least one measurable lesion (spiral CT scan long diameter ≥10 mm or enlarged lymph node short diameter ≥15 mm by RECIST 1.1); * Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy; * ECOG PS ≤1; * Expected overall survival≥12 weeks; Exclusion Criteria: * Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks; * Other kinds of malignancies \[excluding stage IB or lower grade cervical cancer，noninvasive basal cell or squamous cell cancer, breast cancer with complete remission (CR) \> 10 years ,melanoma with CR \> 10 years or other malignant tumors with CR \> 5 years\]; * Hematologic, renal, and hepatic function abnormities as defined below: Absolute neutrophil count (ANC) \<1.5×109 /L or platelet \<100×109 /L or hemoglobin \<9 g/dL; Total bilirubin \> 1.5×the upper limit of normal range(ULN) without liver metastases; total bilirubin \> 3×ULN with liver metastases; AST, ALT, ALP \>1.5×ULN without liver metastases ; AST, ALT, ALP \>5×ULN with liver metastases; Primary hepatocellular carcinoma; Hepatic cirrhosis with Child-Pugh B or C; Serum creatinine \>1.5×ULN; History of previous nephrotic syndrome; INR or aPPT \>1.5×ULN; Presence of hemorrhage (hemoptysis) , thrombosis，or currently receiving treatment with warfarin, aspirin, low molecular weight heparin (LMWH), or any other anti-platelet drugs (Aspirin ≤100 mg/d for prophylaxis are allowed); •Any of the following gastrointestinal disease: Unable to swallow oral drugs; Need intravenous nutrition; History of a gastric resection; History of treatment for active peptic ulcer disease within 6 months; Clinically significant gastrointestinal bleeding within 3 months; Persistent grade 2 or higher chronic diarrhea despite optimal medical management; •Any of the following cardiovascular and cerebrovascular disease: Myocardial infarction , severe cardiac arrhythmias, unstable angina, coronary artery disease, congestive heart failure, cerebrovascular accident or TIA within 12 months ; Deep vein thrombosis or pulmonary embolism within 6 months; QTcF \>470 msec; Uncontrolled hypertension despite optimal medical management; * Presence of unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 grade 0 or 1 with the exception of alopecia; * Involved in other clinical trials within 30 days of enrollment; * Major surgical procedure, open biopsy, or significant traumatic injury within 30 days of enrollment; * History of organ allograft ; * Need glucocorticoids or other immunosuppressive agents for immunosuppression (excluding local or inhaled glucocorticoids); * Uncontrolled ongoing or active infection; * Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy; * Pregnant or lactating women or those who do not take contraceptives, including men; * Suffering from mental and neurological diseases; * Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings; * Inability to comply with protocol required procedures.
Contact & Investigator
Yuankai Shi, Doctor
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT04093466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04093466 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04093466 currently recruiting?
Yes, NCT04093466 is actively recruiting participants. Contact the research team at wujy@konruns.cn for enrollment information.
Where is the NCT04093466 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04093466 clinical trial?
NCT04093466 is sponsored by Beijing Konruns Pharmaceutical Co., Ltd.. The principal investigator is Yuankai Shi, Doctor at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 126 participants.