Spots Global Cancer Trial Database for A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors
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Trial Identification
Brief Title: A Phase 1/2 Study of Donafenib in Combination With KN046 in 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
Study ID: NCT04612712
Conditions
Study Description
Brief 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.
Detailed Description: The study consists of dose escalation and dose expansion. The preset dose of Donafenib is 50 mg BID, 100 mg BID and 200 mg BID, and the preset dose of KN046 is 5 mg/kg Q3W. Dose expansion will enroll subjects who with advanced hepatocellular carcinoma.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Zhongshan Hospital Affiliated to Fudan University, Shanghai, , China
Contact Details
Name: Tianshu Liu, PhD
Affiliation: Shanghai Zhongshan Hospital
Role: STUDY_CHAIR
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