To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Digestive System Tumors
In brief
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.
Key facts
- Study ID
- NCT05260385
- Run by
- Beijing Konruns Pharmaceutical Co., Ltd.
- People needed
- 133
- Starts
- 2022-01-24
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2024-10-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, China (enrolling)
- The first affiliated hospital of bengbu medical college — Bengbu, China (enrolling)
- Chongqing University Three Gorges Hospital — Chongqing, China (enrolling)
- Fujian Cancer Hospital — Fujian, China (enrolling)
- Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Henan, China (enrolling)
- The First Affiliated Hospital of Xinxiang Medical University — Henan, China (enrolling)
- Hubei Cancer Hospital — Hubei, China (enrolling)
- Union Hospital Tongji Medical College Huazhong University of Science and Technologe — Hubei, China (enrolling)
- Shandong Cancer Hospital & Institute — Shandong, China (enrolling)
- Shanghai Chest Hospital — Shanghai, China (enrolling)
- Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center — Shenzhen, China (enrolling)
- Tianjin Medical University Cancer Institute &Hospital — Tianjin, China (enrolling)
- The Second Affiliated Hospital Zhejiang University School of Medicine — Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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