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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

Sponsor
Byondis B.V. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04983238
Collaborator
(none)
196
Enrollment
10
Locations
2
Arms
35.7
Anticipated Duration (Months)
19.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: BYON5667 & SYD985
  • Drug: Placebo & SYD985
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 10, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: BYON5667 & SYD985

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

Drug: BYON5667 & SYD985
Ocular administration: BYON5667, Intravenous administration: SYD985
Other Names:
  • BYON5667: sodium thiosulfate
  • SYD985: (vic-)trastuzumab duocarmazine

    		•
    Placebo Comparator: Placebo & SYD985

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

    Drug: Placebo & SYD985
    Ocular administration: Placebo, Intravenous administration: SYD985
    Other Names:
  • SYD985: (vic-)trastuzumab duocarmazine

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Secondary Outcome Measures

    1. Ocular toxicity [Day 63 or Day 126]

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

    2. Tolerability of BYON5667 eye drops by means of Eye Drop Tolerability questionnaire scores [Up to 2 years]

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

    3. National Eye Institute Visual Function Questionnaire (NEI VFQ-25) scores [Up to 2 years]

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

    4. SYD985-related ocular adverse events (AE) [Up to 2 years]

      Time to first SYD985-related ocular AE

    5. Discontinuation due to SYD985-related ocular toxicity [Up to 2 years]

      Percentage of patients discontinued due to SYD985-related ocular toxicity

    6. Efficacy of SYD985 by assessing the objective response rate (ORR) [Up to 2 years]

      Efficacy of SYD985

    7. Efficacy of SYD985 by assessing the progression-free survival (PFS) [Up to 2 years]

      Efficacy of SYD985

    8. Efficacy of SYD985 by assessing the overall survival [Up to 2 years]

      Efficacy of SYD985

    9. Safety of SYD985 by assessing incidence and severity of treatment-emergent drug-related adverse events [Up to 2 years]

      Safety of SYD985

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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;

    1. 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;

    1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;

    2. Patient should refrain from wearing any kind of contact lenses during trial treatment;

    3. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Antwerp Antwerp Belgium 2650
    2 UZ Leuven Leuven Belgium 3000
    3 Institut Bergonié Bordeaux France 33076
    4 Centre Oscar Lambret Lille France 59020
    5 Hôpital Saint Louis Paris France 75475
    6 Vall d' Hebron Barcelona Spain 8035
    7 ICO I'Hospitalet - Hospital Duran i Reynals L'Hospitalet De Llobregat Spain 8908
    8 Hospital Universitari Arnau de Vilanova Lleida Spain 25198
    9 START Madrid HU Fundacion Jimenez Diaz Madrid Spain 28040
    10 START Madrid HU HM Sanchinarro Madrid Spain 28050

    Sponsors and Collaborators

    • Byondis B.V.

    Investigators

    • Study Director: Ellen Mommers, PhD, Byondis B.V., The Netherlands

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Byondis B.V.
    ClinicalTrials.gov Identifier:
    NCT04983238
    Other Study ID Numbers:
    • BYON5667.002
    First Posted:
    Jul 30, 2021
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Toxic Optic Neuropathy
    Sodium thiosulfate
    Trastuzumab

    Study Results

    No Results Posted as of Aug 4, 2022