Clinical trial · Interventional
A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521
A First-in-human Dose-escalation and Expansion Trial With the Antibody-drug Conjugate BYON3521 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With c-MET Expressing Locally Advanced or Metastatic Solid Tumours
NCT05323045CI-TRIAL-00091927completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BYON3521 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BYON3521
- description
- c-MET targeting Antibody-Drug Conjugate
- interventionNames
- Drug: BYON3521
Primary outcomes (1)
- measure
- Incidence of dose-limiting toxicities
- timeFrame
- 21 days
- description
- Part 1
Secondary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 21 days
- description
- Part 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGroothuis PG, Jacobs DCH, Hermens IAT, Damming D, Berentsen K, Mattaar-Hepp E, Stokman MEM, Boekel TV, Rouwette M, van der Vleuten MAJ, Sesink A, Dijcks FA, Coumans RGE, Schouten J, Glaudemans DH, Wijk DV, Blomenrohr M, Kappers WA, Ubink R, van der Lee MMC, Dokter WHA. Preclinical Profile of BYON3521 Predicts an Effective and Safe MET Antibody-Drug Conjugate. Mol Cancer Ther. 2023 Jun 1;22(6):765-777. doi: 10.1158/1535-7163.MCT-22-0596. PMID 37042205