To Evaluate KC1036 in the Patients With Advanced Digestive System Tumors

• Status: Not yet recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

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;

• 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 or imaging shows a risk of CNS metastasis;

• Other kinds of malignancies;

• Hematologic, renal, and hepatic function abnormities;

• Risk of bleeding;

• Gastrointestinal abnormalitiest;

• Cardiovascular and cerebrovascular diseases;

• Disease progression after previous treatment with PD-1 / PD-L1 antibody combined with small molecule vascular targeting inhibitor；Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks before enrollment;

• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia, ≤ grade 2 neuropathy, non clinically significant and asymptomatic laboratory abnormalities;

• Involved in other clinical trials within 4 weeks before enrollment;

• Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks before enrollment;

• History of organ allograft ;

• Need immunosuppressive agents or hormone therapy for immunosuppression, and still need immunosuppressive therapy within 2 weeks before enrollment;

• Uncontrolled ongoing or active bacterial, viral or fungal infectious; Fever of unknown cause (> 38.5 ℃) occurred within 2 weeks before enrollment; Known history or evidence of interstitial lung disease or non infectious pneumonia treated with corticosteroids;

• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;

• Pregnant or lactating women or those who do not take contraceptives, including men;

• Suffering from mental and neurological diseases;

• Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;

• Inability to comply with protocol required procedures.