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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05323045
Other study ID # BYON3521.001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 21, 2022
Est. completion date July 2024

Study information

Verified date June 2024
Source Byondis B.V.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is the first-in-human trial with BYON3521, an antibody-drug conjugate (ADC) comprising a humanized IgG1 monoclonal antibody directed against the c-MET receptor covalently conjugated to a duocarmycin-containing linker-drug.


Description:

This trial includes a dose-escalation part (Part 1) in which the MTD and RDE will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts. BYON3521 is an ADC comprising a humanized IgG1 monoclonal antibody (mAb) directed against the c-MET receptor covalently and site-specifically conjugated to a duocarmycin-containing linkerdrug.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 31
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with histologically-confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists: - Part 1 (dose-escalation): solid tumours of any origin; - Part 2 (expansion): - Cohort A: Non-squamous non small cell lung cancer (non-squamous NSCLC); - Cohort B: Gynaecological cancers: ovarian cancer, endometrial cancer, cervical cancer; - Cohort C: Pancreatic adenocarcinoma (PA); - Cohort D: Uveal melanoma (UM). - c-MET prevalence confirmed by: - Part 1: Tumour c-MET positive membrane staining by immunohistochemistry (IHC) and/or MET amplification by dual In Situ Hybridization (dISH) and/or known MET-mutation; - Part 2: Tumour c-MET membrane expression by immunohistochemistry (IHC score = 2+) as determined by the central laboratory on most recent available/obtained tumour material from a site not previously irradiated; - Eastern Cooperative Oncology Group (ECOG) performance status = 1; - Adequate organ function Exclusion Criteria: - Having been treated with: - Trastuzumab duocarmazine (SYD985) at any time; - Other anticancer therapy within 4 weeks or as defined in the protocol; - History or presence of keratitis, glomerulonephritis, 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 (within 6 months prior to start IMP) or presence of clinically significant cardiovascular disease such as unstable angina, congestive heart failure, myocardial infarction, uncontrolled hypertension, or cardiac arrhythmia requiring medication; - Symptomatic brain metastases, brain metastases requiring steroids or treatment for brain metastases within 8 weeks

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BYON3521
BYON3521 (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.

Locations

Country Name City State
Belgium Institut Jules Bordet Brussels
Italy Istituto Europeo di Oncologia Milan
Netherlands Radboud Nijmegen
United Kingdom Royal Marsden London

Sponsors (1)

Lead Sponsor Collaborator
Byondis B.V.

Countries where clinical trial is conducted

Belgium,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dose-limiting toxicities Part 1 21 days
Secondary Objective response rate Part 2 21 days
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