Clinical trial
A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients With Advanced Recurrent or Metastatic Digestive System Tumors
Name
KC1036-II-01
Description
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.
Trial arms
Trial start
2022-01-24
Estimated PCD
2024-04-30
Trial end
2025-04-30
Status
Recruiting
Phase
Early phase I
Treatment
KC1036
KC1036 are administered orally QD or BID in 21-day cycles.
Arms:
BID regimen, QD regimen
Size
133
Primary endpoint
Objective Response Rate (ORR)
approximately 2 year.
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 133, 'type': 'ESTIMATED'}}
Updated at
2023-01-03
1 organization
1 product
1 abstract
1 indication
Organization
Beijing Konruns PharmaceuticalProduct
KC1036Indication
Digestive System TumorsAbstract
KC1036, a novel oral multi-kinase inhibitor, in patients with previously treated advanced esophageal squamous cell carcinoma (ESCC): Results from a multicenter, single-arm phase II trial.Org: National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Oncology Department, the First Affiliated Hospital of Xinxiang Medical College, Chongqing University Three Gorges Hospital & Chongqing Three Gorges Central Hospital, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tianjin Medical University Cancer Institute & Hospital,National Clinical Research Center for Cancer,