Status:
RECRUITING
To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors
Lead Sponsor:
Beijing Konruns Pharmaceutical Co., Ltd.
Conditions:
Digestive System Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
This is an open label, non-randomized，phase 1b/2 study to explore the preliminary antitumor activity of KC1036 in patients with advanced recurrent or metastatic digestive system tumors under BID or QD...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT05260385
Start Date
January 24 2022
End Date
December 30 2025
Last Update
October 17 2024
Active Locations (13)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
2
The first affiliated hospital of bengbu medical college
Bengbu, China
3
Chongqing University Three Gorges Hospital
Chongqing, China
4
Fujian Cancer Hospital
Fujian, China