drugset / Trial / NCT04363801
A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Timeline
- Start
- 2020-07-29
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
Publications
- Rha SY, Ryu MH, Kim JG, Xu S, Xu Y, Lee KW. Comparative efficacy of tislelizumab + FOLFOX or CAPOX for gastric/gastroesophageal junction adenocarcinoma: an exploratory matching-adjusted indirect comparison. Curr Med Res Opin. 2026 Jun 29:1-11. doi: 10.1080/03007995.2026.2686048. Online ahead of print.
- Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.
- Klempner SJ, Sonbol MB, Wainberg ZA, Uronis HE, Chiu VK, Scott AJ, Iqbal S, Tejani MA, Chung V, Stilian MC, Thoma M, Zhang Y, Kagey MH, Baum J, Sirard CA, Altura RA, Ajani JA. DKN-01 in Combination With Tislelizumab and Chemotherapy as First-Line Therapy in Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: DisTinGuish. J Clin Oncol. 2025 Jan 20;43(3):339-349. doi: 10.1200/JCO.24.00410. Epub 2024 Oct 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | DKN-01 | Monoclonal antibody | 300 mg | Intravenous |
| Subject | DKN-01 | Monoclonal antibody | 400 mg | Intravenous |
| Subject | DKN-01 | Monoclonal antibody | 600 mg | Intravenous |
| Subject | Leucovorin | Small molecule | — | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | fluorouracil | Small molecule | — | Intravenous |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |