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

NCT04983238 | Completed Phase 1 DMC

• 1 other identifier: BYON5667.002
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 10

Brief 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

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of BYON5667 eye drops by assessing the percentage of patients with SYD985-related ocular adverse events Grade >=1 at Day 63

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

  63 days

Secondary Outcomes (9)

• Ocular toxicity

  Day 63 or Day 126

• Tolerability of BYON5667 eye drops by means of Eye Drop Tolerability questionnaire scores

  Up to 2 years

• National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores

  Up to 2 years

• SYD985-related ocular adverse events (AE)

  Up to 2 years

• Discontinuation due to SYD985-related ocular toxicity

  Up to 2 years

Study Arms (2)

BYON5667 & SYD985

EXPERIMENTAL

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

Drug: BYON5667 & SYD985

Placebo & SYD985

PLACEBO COMPARATOR

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

Drug: Placebo & SYD985

Interventions

BYON5667 & SYD985 DRUG

Ocular administration: BYON5667, Intravenous administration: SYD985

Also known as: BYON5667: sodium thiosulfate, SYD985: (vic-)trastuzumab duocarmazine

BYON5667 & SYD985

Placebo & SYD985 DRUG

Ocular administration: Placebo, Intravenous administration: SYD985

Also known as: SYD985: (vic-)trastuzumab duocarmazine

Placebo & SYD985

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥18 years at the time of signing first informed consent;
• Patient with histologically-confirmed, unresectable locally advanced or metastatic cancer with the following restriction:
• Single arm part: patient with solid tumours of any origin (excluding gastric tumours and adenocarcinomas of the gastroesophageal junction) who has progressed on standard therapy or for whom no standard therapy exists; Randomized part: patient with breast cancer who had either progression during or after at least two human epidermal growth factor receptor 2 (HER2)-targeting treatment regimens for locally advanced or metastatic disease, or progression during or after \[ado-\]trastuzumab emtansine treatment for locally advanced or metastatic disease;
• HER2 tumour status as determined by a local laboratory using immunohistochemistry (IHC) and/or in situ hybridization (ISH):
• Single arm part: at least IHC 1+; Randomized part: IHC 3+ and/or ISH positive;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
• Patient should refrain from wearing any kind of contact lenses during trial treatment;
• Adequate organ function

You may not qualify if:

• Current or previous use of prohibited medication as listed in the protocol
• History of infusion-related reactions and/or hypersensitivity to trastuzumab containing treatment or excipients of the trial treatments which led to permanent discontinuation of the treatment;
• History or presence of keratitis;
• Left ventricular ejection fraction (LVEF) \< 50%, or a history of clinically significant decrease in LVEF during previous trastuzumab containing treatment leading to permanent discontinuation of treatment;
• History or presence of idiopathic pulmonary fibrosis, organizing pneumonia (e.g. bronchiolitis obliterans), drug-induced or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan;
• History or presence of clinically significant cardiovascular disease;
• Severe, uncontrolled systemic disease;
• Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks.

Sponsors & Collaborators

• Byondis B.V.: lead

Study Sites (10)

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Hôpital Saint Louis

Paris, 75475, France

Location

Vall d' Hebron

Barcelona, 8035, Spain

Location

ICO I'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, 8908, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

START Madrid HU Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

START Madrid HU HM Sanchinarro

Madrid, 28050, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab duocarmazine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ellen Mommers, PhD

  Byondis B.V., The Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 30, 2021
• Study Start: January 10, 2022
• Primary Completion: April 19, 2023
• Study Completion: June 26, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); ES (5); FR (3)