A Phase 1/2 interventional study of BYON5667 & SYD985 and Placebo & SYD985 in Metastatic Breast Cancer, sponsored by Byondis B.V.. Completed at 10 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Byondis B.V. · Phase 1/2, Interventional, and Prevention
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
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.
Main Inclusion Criteria:
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;
Main Exclusion Criteria:
BYON5667 eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)
Drug: BYON5667 & SYD985
Placebo eye drops should be self-administered daily during waking hours. SYD985, every 3 weeks (Q3W)
Drug: Placebo & SYD985
Ocular administration: BYON5667, Intravenous administration: SYD985
Also known as: BYON5667: sodium thiosulfate, SYD985: (vic-)trastuzumab duocarmazine
Ocular administration: Placebo, Intravenous administration: SYD985
Also known as: SYD985: (vic-)trastuzumab duocarmazine
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
Time frame: 63 days
Ocular toxicity
Percentage of patients with SYD985-related ocular toxicity of different grades at Day 63 or Day 126
Time frame: 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)
Time frame: Up to 2 years
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
Time frame: Up to 2 years
SYD985-related ocular adverse events (AE)
Time to first SYD985-related ocular AE
Time frame: Up to 2 years
Discontinuation due to SYD985-related ocular toxicity
Percentage of patients discontinued due to SYD985-related ocular toxicity
Time frame: Up to 2 years
Efficacy of SYD985 by assessing the objective response rate (ORR)
Efficacy of SYD985
Time frame: Up to 2 years
Efficacy of SYD985 by assessing the progression-free survival (PFS)
Efficacy of SYD985
Time frame: Up to 2 years
Efficacy of SYD985 by assessing the overall survival
Efficacy of SYD985
Time frame: Up to 2 years
Safety of SYD985 by assessing incidence and severity of treatment-emergent drug-related adverse events
Safety of SYD985
Time frame: Up to 2 years
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Toxic Optic Neuropathy
Byondis B.V.