To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors
NCT ID: NCT05260385
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
133 participants
INTERVENTIONAL
2022-01-24
2025-12-30
Brief Summary
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Detailed Description
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The study will consist of two parts:
Part 1: QD regimen
To evaluate the efficacy and safety of KC1036 in the treatment of advanced recurrent, unresectable and / or metastatic digestive system tumors under 60mg QD regimen.
Part 2: BID regimen
Dose-Escalation part : To explore the safety of KC1036 under 20mg BID, 30mg BID and 40mg BID in patients with advanced recurrent or metastatic digestive system tumors.
Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion to evaluate the effectiveness and safety of KC1036 in patients with advanced recurrent, unresectable and / or metastatic digestive system tumors.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QD regimen
KC1036 was administered orally in 60 mg once daily, 21 days as a cycle.
KC1036
KC1036 are administered orally QD or BID in 21-day cycles.
BID regimen
Dose-Escalation part : KC1036 was administered orally in 20 mg BID, 30 mg BID, or 40 mg BID.
Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion .
KC1036
KC1036 are administered orally QD or BID in 21-day cycles.
Interventions
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KC1036
KC1036 are administered orally QD or BID in 21-day cycles.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Beijing Konruns Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, , China
The first affiliated hospital of bengbu medical college
Bengbu, , China
Chongqing University Three Gorges Hospital
Chongqing, , China
Fujian Cancer Hospital
Fujian, , China
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Henan, , China
The First Affiliated Hospital of Xinxiang Medical University
Henan, , China
Hubei Cancer Hospital
Hubei, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technologe
Hubei, , China
Shandong Cancer Hospital & Institute
Shandong, , China
Shanghai Chest Hospital
Shanghai, , China
Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
Shenzhen, , China
Tianjin Medical University Cancer Institute &Hospital
Tianjin, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, , China
Countries
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Central Contacts
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Facility Contacts
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Hao Jiang
Role: primary
Li Zhang
Role: primary
Wu Zhuang
Role: primary
Ning Li
Role: primary
Liuzhong Yang
Role: primary
Huiting Xu
Role: primary
Tao Zhang
Role: primary
Zuoxing Niu
Role: primary
Ming Zhang
Role: primary
Ying Wang
Role: primary
Peng Tang
Role: primary
Ying Yuan
Role: primary
Other Identifiers
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KC1036-II-01
Identifier Type: -
Identifier Source: org_study_id
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