drugset / Trial / NCT04641871

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies

NCT04641871

Phase 1 Completed 78 enrolled Symphogen A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations

Timeline

Start
2020-10-12
Primary completion
2024-06-03
Completion
2024-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule Intravenous
Subject Sym021 Monoclonal antibody Intravenous
Subject Sym022 Unknown Intravenous
Subject Sym023 Monoclonal antibody Intravenous