Clinical trialPhase 1 / Phase 2Terminated
A Phase 1/2 Study of Donafenib in Combination With KN046 in Advanced Gastrointestinal Tumors
A Phase 1/2 Dose Escalation and Expansion Study of Donafenib Tosilate Tablets in Combination With KN046 Injection in Advanced Gastrointestinal Tumors
- Outcome
- Stopped earlyDue to R\&D strategy adjustments; no safety issues involved. (Business decision)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 19 January 2021
- Ended
- 30 June 2022
- Enrollment
- 15 participants
- Sites
- 1
- Primary outcomes
- Phase I part - Tolerability of Donafenib in Combination With KN046; Phase II part - Objective response rate(ORR)
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 1 May 2026
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.