Status:
COMPLETED
A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521
Lead Sponsor:
Byondis B.V.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 duocarmy...
Detailed 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05323045
Start Date
March 21 2022
End Date
September 25 2024
Last Update
July 9 2025
Active Locations (4)
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1
Institut Jules Bordet
Brussels, Belgium
2
Istituto Europeo di Oncologia
Milan, Italy, 1070
3
Radboud
Nijmegen, Netherlands, 6500HB
4
Royal Marsden
London, United Kingdom, SM2 5PT