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

NCT04983238 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-01-05

No results posted yet for this study

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

Conditions

Interventions

DRUG

BYON5667 & SYD985

Ocular administration: BYON5667, Intravenous administration: SYD985

DRUG

Placebo & SYD985

Ocular administration: Placebo, Intravenous administration: SYD985

Sponsors & Collaborators

  • Byondis B.V.

    lead INDUSTRY

Principal Investigators

  • Ellen Mommers, PhD · Byondis B.V., The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium
  • France
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04983238 on ClinicalTrials.gov