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BYON5667 eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)

Placebo eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)

Ocular administration: BYON5667, Intravenous administration: SYD985

BYON5667 & SYD985

Ocular administration: Placebo, Intravenous administration: SYD985

Placebo & SYD985

Ellen Mommers, PhD

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

This multicenter trial has a single arm run-in period followed by a randomized, placebo-controlled, double-blind comparative part. In the single arm part of the trial, patients with HER2-expressing locally advanced or metastatic solid tumours will be enrolled and treated with the antibody-drug conjugate (ADC) SYD985 once every 3 weeks until disease progression or unacceptable toxicity. All patients will receive concomitant BYON5667 eye drops. When the primary safety and efficacy analysis of the BYON5667 eye drops at Day 63 is favorable, the trial may continue to the comparative part in which patients with locally advanced or metastatic HER2-positive breast cancer will be treated with SYD985. Patients will be randomly assigned (1:1) to receive BYON5667 or placebo eye drops.

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial With a Single Arm run-in Period to Evaluate the Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985

Percentage of patients with SYD985-related ocular toxicity Grade ≥1 at Day 63

Percentage of patients with SYD985-related ocular toxicity of different grades at Day 63 or Day 126

Tolerability of BYON5667 eye drops Questionnaire includes 5 questions with score of 0 (no discomfort) to 10 (most imaginable discomfort)

Self-reported validated questionnaire including 25 questions with scores of 1 to maximum 6, from best/worst to worst/best depending on the question

Percentage of patients discontinued due to SYD985-related ocular toxicity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985	NCT04983238	Metastatic Brea...	BYON5667 & SYD9... Placebo & SYD98...	18 Years -	Byondis B.V.
Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985	NCT04983238	Metastatic Brea...	BYON5667 & SYD9... Placebo & SYD98...	18 Years -	Byondis B.V.
Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985	NCT04983238	Metastatic Brea...	BYON5667 & SYD9... Placebo & SYD98...	18 Years -	Byondis B.V.

Spots Global Cancer Trial Database for placebo & syd985