drugset / Trial / NCT04983238

Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985

NCT04983238

Phase 1/2 Completed 48 enrolled Byondis B.V.
RandomizedParallel-groupTriple-blindPrevention

Summary

This multicenter, randomized, double-blind, placebo-controlled trial with a single arm run-in period is to evaluate the safety and efficacy of sodium thiosulfate (BYON5667) eye drops to reduce ocular toxicity in cancer patients treated with the antibody-drug conjugate (ADC) SYD985

Timeline

Start
2022-01-10
Primary completion
2023-04-19
Completion
2023-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject BYON5667 Unknown Other
Background Trastuzumab duocarmazine Other / unclassified Intravenous

Indications