A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open, multi-center clinical trial, the purpose is to study the safety and preliminary efficacy of Donafenib combined with KN046 in subjects with Advanced Gastrointestinal Tumors.

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

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Collaborator: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Criteria

Inclusion Criteria:

• Male or female aged 18-70 years;

• Phase I dose escalation: Advanced gastric cancer, esophageal cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer (other than pancreatic neuroendocrine tumors) and intrahepatic cholangiocarcinoma that failed standard treatments confirmed by histopathology and/or cytology; Among them, the Child-Pugh score of liver function in patients with hepatocellular carcinoma is less than 5,

• Phase II advanced hepatocellular carcinoma Dose expansion: Patients with advanced hepatocellular carcinoma who are clinically diagnosed or confirmed by histopathology and/or cytology and are not suitable for surgical resection; The patient has not undergone first-line systemic treatment [small molecule targeted drugs (such as sorafenib, lenvatinib, etc.), systemic chemotherapy] and tumor immunotherapy (anti-PD-1/L1, CTLA-4, etc.); Child-Pugh score of liver function ≤ 6;

• Has at least one measurable lesion based on RECIST 1.1;

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;

• Life expectancy ≥12 weeks;

• Patients must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Subjects who have previously received immune checkpoint inhibitors (such as anti-PD-1/L1, CTLA-4, etc.);

• History of interstitial lung disease or non-infectious pneumonia;

• Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients undergoing total gastrectomy;

• Has received vaccination within 4 weeks prior to the first dose.

• Has participated in other anticancer drug clinical trials within 4 weeks.

• According to the judgement of the investigators, there are other factors that subjects are not suitable for the study.