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A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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.
Official title: A Phase 1/2 Dose Escalation and Expansion Study of Donafenib Tosilate Tablets in Combination With KN046 Injection in Advanced Gastrointestinal Tumors
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2021-01-19
Completion Date
2022-06-30
Last Updated
2026-05-01
Healthy Volunteers
No
Conditions
Interventions
Donafenib Tosilate Tablets
In the dose exploration phase (phase I) : three doses of Donafenib tosylate tablets \[50 mg twice a day; 100 mg twice a day; 200 mg twice a day \] will be explored. In the dose expansion phase (phase II), patients with advanced hepatocellular carcinoma will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study.
KN046 Injection
5mg/kg Q3W
Locations (1)
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China