Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04093466

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here