Testing CX1003 for advanced solid tumors

A Phase 1, Multicenter, Open-label, Dose Escalation/expansion Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of CX1003 (Kanitinib) in the Patients with Relapsed Advanced or Metastatic Solid Tumors

This study is testing a new drug called CX1003 to see if it can help people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04093466 on ClinicalTrials.gov

What this trial studies

This study evaluates CX1003, a novel multi-target tyrosine kinase inhibitor, in patients with advanced solid tumors that are refractory to standard therapies. The primary focus is on assessing the safety, pharmacokinetics, and antitumor activity of CX1003, particularly its ability to inhibit VEGFR2 and HGFR/MET. Patients with measurable lesions and documented disease progression after prior treatments will be enrolled to determine the drug's effectiveness and tolerability.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically confirmed recurrent or metastatic solid tumors who have measurable lesions and have progressed after standard treatments.

Not a fit: Patients with untreated brain metastases or those with other malignancies that do not meet specific criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have not responded to existing therapies.

How similar studies have performed: Other studies involving multi-target tyrosine kinase inhibitors have shown promise in treating advanced solid tumors, suggesting potential for success in this approach.

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.

Where this trial is running

Beijing, Beijing Municipality

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yuankai Shi, Doctor — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Junyu Wu, Ph.D

Conditions Advanced Solid Tumor