A Phase 1 Study of CX1003 (Kanitinib) in Patients with Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Konruns Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
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;
Disqualifiers
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];
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;
Trial design
Treatments tested in this trial
- CX1003
Treatment groups
126 Participants
are divided into 1 treatment groupSponsors and collaborators
Beijing Konruns Pharmaceutical Co., Ltd.
Lead sponsor
Chinese Academy of Medical Sciences
Collaborator
West China Hospital
Collaborator
Beijing Tongren Hospital
Collaborator
Source ClinicalTrials.gov