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Metastatic Breast CancerPhase 1/2NCT04983238

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

A Phase 1/2 study testing BYON5667 & SYD985 in people with Metastatic Breast Cancer, run by Byondis B.V. at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
BYON5667 & SYD985
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
10 sitesin 3 countries
Study dates
10 Jan 2022to 26 Jun 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

Spain5 sites

  • Vall d' Hebron

    Barcelona, 8035

  • ICO I'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 8908

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • START Madrid HU Fundacion Jimenez Diaz

    Madrid, 28040

  • START Madrid HU HM Sanchinarro

    Madrid, 28050

Other trials in Spain

France3 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Oscar Lambret

    Lille, 59020

  • Hôpital Saint Louis

    Paris, 75475

Other trials in France

Belgium2 sites

  • University Hospital Antwerp

    Antwerp, 2650

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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

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

Read the 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.

Being tested
BYON5667 & SYD985, Placebo & SYD985
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BYON5667 & SYD985Drug

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

    Ocular administration: BYON5667, Intravenous administration: SYD985

  • Placebo & SYD985Drug

    Also called SYD985: (vic-)trastuzumab duocarmazine

    Ocular administration: Placebo, Intravenous administration: SYD985

Study groups in NCT04983238
Study groupRoleWhat they receive
BYON5667 & SYD985ExperimentalBYON5667 eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)
Receives: Drug: BYON5667 & SYD985
Placebo & SYD985Placebo comparatorPlacebo eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)
Receives: Drug: Placebo & SYD985

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 63 days

Secondary outcomes (9)

  1. Ocular toxicity

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

    Measured: Day 63 or Day 126

  2. 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)

    Measured: Up to 2 years

  3. 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

    Measured: Up to 2 years

  4. SYD985-related ocular adverse events (AE)

    Time to first SYD985-related ocular AE

    Measured: Up to 2 years

  5. Discontinuation due to SYD985-related ocular toxicity

    Percentage of patients discontinued due to SYD985-related ocular toxicity

    Measured: Up to 2 years

  6. Efficacy of SYD985 by assessing the objective response rate (ORR)

    Efficacy of SYD985

    Measured: Up to 2 years

  7. Efficacy of SYD985 by assessing the progression-free survival (PFS)

    Efficacy of SYD985

    Measured: Up to 2 years

  8. Efficacy of SYD985 by assessing the overall survival

    Efficacy of SYD985

    Measured: Up to 2 years

  9. Safety of SYD985 by assessing incidence and severity of treatment-emergent drug-related adverse events

    Safety of SYD985

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start10 Jan 2022
  3. Primary completion19 Apr 2023
  4. Study completion26 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983238
Sponsor's protocol ID
BYON5667.002
Status last verified
Jan 2024
First submitted
12 Jul 2021
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BYON5667 & SYD985 in people with Metastatic Breast Cancer, run by Byondis B.V. at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain, France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of BYON5667 eye drops by assessing the percentage of patients with SYD985-related ocular adverse events Grade >=1 at Day 63 (time frame: 63 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983238.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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