KC1036: KC1036 are administered orally QD or BID in 21-day cycles.
Study summary
The purpose of this study is to evaluate the preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Histologically or cytologically confirmed malignant digestive system tumors;
* Patients with advanced recurrent, unresectable and / or metastatic digestive system tumors who have failed standard or conventional treatment:( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
* Eastern Cooperative Oncology Group performance status score of 0 or 1;
* Life expectancy \> 12 weeks;
* BMI≥18.0;
* Has adequate Hematologic, renal, and hepatic function;
* Patients should participate in the study voluntarily and sign informed consent.
Exclusion Criteria:
* Any patient who is known to have central nervous system (CNS) metastasis with clinical symptoms;
* Other kinds of malignancies;
* Gastrointestinal abnormalitiest;
* Cardiovascular and cerebrovascular diseases;
* Previous treatment with small molecule vascular targeting inhibitor;
* Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks before enrollment;
* Involved in other clinical trials within 4 weeks before enrollment;
* Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks before enrollment;
* Uncontrolled massive ascites,pleural/pericardial effusion;
* Uncontrolled ongoing or active bacterial, viral or fungal infectious; Fever of unknown cause (\> 38.5 ℃) occurred within 2 weeks before enrollment;
* Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection ;
* Pregnant or lactating women or those who do not take contraceptives, including men;
* Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
* Inability to comply with protocol required procedures.
Primary outcome measure(s)
Objective Response Rate (ORR) — approximately 2 year. Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.
Trial sites (13)
Facility
City
Region
Status
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
China
Recruiting
The first affiliated hospital of bengbu medical college
Bengbu
China
Recruiting
Chongqing University Three Gorges Hospital
Chongqing
China
Recruiting
Fujian Cancer Hospital
Fujian
China
Recruiting
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Henan
China
Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Henan
China
Recruiting
Hubei Cancer Hospital
Hubei
China
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technologe
Hubei
China
Recruiting
Shandong Cancer Hospital & Institute
Shandong
China
Recruiting
Shanghai Chest Hospital
Shanghai
China
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
Shenzhen
China
Recruiting
Tianjin Medical University Cancer Institute &Hospital
Tianjin
China
Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang
China
Recruiting
More Beijing Konruns Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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