NCT05260385 To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors
| NCT ID | NCT05260385 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Beijing Konruns Pharmaceutical Co., Ltd. |
| Condition | Digestive System Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 133 participants |
| Start Date | 2022-01-24 |
| Primary Completion | 2025-10-30 |
Trial Parameters
Eligibility Fast-Check
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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.
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,