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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

CX1003
Drug
Oral dose A 4-day single dose period, followed by a period of daily-dose in continuous 28-day treatment cycle (the 1st cycle) or 21-day treatment cycles (the 2nd cycle and beyond) Dosage range: 25 mg, 50mg, 75mg, 100mg,125mg,150mg,175mg

Treatment groups

126 Participants

are divided into 1 treatment group

Group A: Treatment (CX1003)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of dose-limiting toxicities (DLTs) by NCI CTCAE 5.0: Dose Escalation Stage

Occurrence of any of the following toxicities was considered DLT if judged by the Investigator to be possibly, probably, or definitely related to the administration of CX1003: * Any Grade 3 or higher non-hematologic toxicity (including persisting nausea, vomiting, diarrhea, and electrolyte imbalances despite optimal medical management); * Grade 4 neutropenia for \>5 consecutive days; * Grade 3 or higher febrile neutropenia; * Grade 3 or higher neutropenia associated with infection; * Grade 4 thrombocytopenia; * Grade 3 or higher thrombocytopenia with clinically significant bleeding or that requires a platelet transfusion.

Time frame