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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

Primary Purpose

Metastatic Breast Cancer

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BYON5667 & SYD985
Placebo & SYD985
Sponsored by
Byondis B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Main Inclusion Criteria:

  1. Male or female, age ≥18 years at the time of signing first informed consent;
  2. 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;

  3. 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;

  4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
  5. Patient should refrain from wearing any kind of contact lenses during trial treatment;
  6. Adequate organ function

Main Exclusion Criteria:

  1. Current or previous use of prohibited medication as listed in the protocol
  2. 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;
  3. History or presence of keratitis;
  4. 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;
  5. 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;
  6. History or presence of clinically significant cardiovascular disease;
  7. Severe, uncontrolled systemic disease;
  8. Symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks.

Sites / Locations

  • University Hospital Antwerp
  • UZ Leuven
  • Institut Bergonié
  • Centre Oscar Lambret
  • Hôpital Saint Louis
  • Vall d' Hebron
  • ICO I'Hospitalet - Hospital Duran i Reynals
  • Hospital Universitari Arnau de Vilanova
  • START Madrid HU Fundacion Jimenez Diaz
  • START Madrid HU HM Sanchinarro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BYON5667 & SYD985

Placebo & SYD985

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ocular toxicity
Percentage of patients with SYD985-related ocular toxicity of different grades at Day 63 or Day 126
Tolerability of BYON5667 eye drops by means of Eye Drop Tolerability questionnaire scores
Tolerability of BYON5667 eye drops Questionnaire includes 5 questions with score of 0 (no discomfort) to 10 (most imaginable discomfort)
National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores
Self-reported validated questionnaire including 25 questions with scores of 1 to maximum 6, from best/worst to worst/best depending on the question
SYD985-related ocular adverse events (AE)
Time to first SYD985-related ocular AE
Discontinuation due to SYD985-related ocular toxicity
Percentage of patients discontinued due to SYD985-related ocular toxicity
Efficacy of SYD985 by assessing the objective response rate (ORR)
Efficacy of SYD985
Efficacy of SYD985 by assessing the progression-free survival (PFS)
Efficacy of SYD985
Efficacy of SYD985 by assessing the overall survival
Efficacy of SYD985
Safety of SYD985 by assessing incidence and severity of treatment-emergent drug-related adverse events
Safety of SYD985

Full Information

First Posted
July 12, 2021
Last Updated
November 2, 2022
Sponsor
Byondis B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT04983238
Brief Title
Evaluation of Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Byondis B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BYON5667 & SYD985
Arm Type
Experimental
Arm Description
BYON5667 eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)
Arm Title
Placebo & SYD985
Arm Type
Placebo Comparator
Arm Description
Placebo eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)
Intervention Type
Drug
Intervention Name(s)
BYON5667 & SYD985
Other Intervention Name(s)
BYON5667: sodium thiosulfate, SYD985: (vic-)trastuzumab duocarmazine
Intervention Description
Ocular administration: BYON5667, Intravenous administration: SYD985
Intervention Type
Drug
Intervention Name(s)
Placebo & SYD985
Other Intervention Name(s)
SYD985: (vic-)trastuzumab duocarmazine
Intervention Description
Ocular administration: Placebo, Intravenous administration: SYD985
Primary Outcome Measure Information:
Title
Efficacy of BYON5667 eye drops by assessing the percentage of patients with SYD985-related ocular adverse events Grade >=1 at Day 63
Description
Percentage of patients with SYD985-related ocular toxicity Grade ≥1 at Day 63
Time Frame
63 days
Secondary Outcome Measure Information:
Title
Ocular toxicity
Description
Percentage of patients with SYD985-related ocular toxicity of different grades at Day 63 or Day 126
Time Frame
Day 63 or Day 126
Title
Tolerability of BYON5667 eye drops by means of Eye Drop Tolerability questionnaire scores
Description
Tolerability of BYON5667 eye drops Questionnaire includes 5 questions with score of 0 (no discomfort) to 10 (most imaginable discomfort)
Time Frame
Up to 2 years
Title
National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores
Description
Self-reported validated questionnaire including 25 questions with scores of 1 to maximum 6, from best/worst to worst/best depending on the question
Time Frame
Up to 2 years
Title
SYD985-related ocular adverse events (AE)
Description
Time to first SYD985-related ocular AE
Time Frame
Up to 2 years
Title
Discontinuation due to SYD985-related ocular toxicity
Description
Percentage of patients discontinued due to SYD985-related ocular toxicity
Time Frame
Up to 2 years
Title
Efficacy of SYD985 by assessing the objective response rate (ORR)
Description
Efficacy of SYD985
Time Frame
Up to 2 years
Title
Efficacy of SYD985 by assessing the progression-free survival (PFS)
Description
Efficacy of SYD985
Time Frame
Up to 2 years
Title
Efficacy of SYD985 by assessing the overall survival
Description
Efficacy of SYD985
Time Frame
Up to 2 years
Title
Safety of SYD985 by assessing incidence and severity of treatment-emergent drug-related adverse events
Description
Safety of SYD985
Time Frame
Up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: 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 Main Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Mommers, PhD
Organizational Affiliation
Byondis B.V., The Netherlands
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Vall d' Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
ICO I'Hospitalet - Hospital Duran i Reynals
City
L'Hospitalet De Llobregat
ZIP/Postal Code
8908
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
START Madrid HU Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
START Madrid HU HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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