NCT04612712

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Gastrointestinal Tumors

Interventions

Type	Name	Description
DRUG	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.
BIOLOGICAL	KN046 Injection	5mg/kg Q3W

Timeline

• Start date: 2021-01-19
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-11-03
• Last updated: 2022-11-29

Locations

1 site across 1 country: China