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
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Terminated
Due to R\&D strategy adjustments; no safety issues involved.
Other terminated trials from Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Advanced Solid Tumor · Phase PHASE1/PHASE2 · Jul 2025
- Colorectal Cancer with Hepatic Metastases · Phase PHASE2 · Jan 2025
- Advanced Solid Tumor · Phase PHASE1 · Nov 2023
- Thymic Carcinoma · Phase PHASE2 · Jul 2023
- Thymic Carcinoma · Phase PHASE2 · May 2023
More terminations from Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Listed as NCT04612712, this observational or N/A phase trial focuses on Advanced Gastrointestinal Tumors and remains terminated or withdrawn. Sponsored by Jiangsu Alphamab Biopharmaceuticals Co., Ltd, it has been updated 8 times since 2021, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
8 versions recorded-
May 4, 2026 — Present [daily]
Terminated
Status: Unknown → Terminated · Phase: PHASE1/PHASE2 → None
-
Dec 2024 — May 2026 [monthly]
Unknown PHASE1/PHASE2
Status: Recruiting → Unknown
-
Sep 2024 — Dec 2024 [monthly]
Recruiting PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
-
Dec 2022 — Jul 2024 [monthly]
Recruiting PHASE1_PHASE2
▶ Show 3 earlier versions
-
Apr 2021 — Dec 2022 [monthly]
Recruiting PHASE1_PHASE2
Status: Not Yet Recruiting → Recruiting
-
Jan 2021 — Apr 2021 [monthly]
Not Yet Recruiting PHASE1_PHASE2
-
Dec 2020 — Jan 2021 [monthly]
Not Yet Recruiting PHASE1_PHASE2
First recorded
Eligibility 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.
Contact Information
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
For direct contact, visit the study record on ClinicalTrials.gov .