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TERMINATED
NCT04612712
PHASE1/PHASE2

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

Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China