Clincosm LogoSign in Get a demo

A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521

Sponsor
Byondis B.V. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05323045
Collaborator
(none)
120
Enrollment
4
Locations
1
Arm
35.4
Anticipated Duration (Months)
30
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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 duocarmycin-containing linker-drug.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 21, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: BYON3521

c-MET targeting Antibody-Drug Conjugate

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of dose-limiting toxicities [21 days]

    Part 1

Secondary Outcome Measures

  1. Objective response rate [21 days]

    Part 2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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: renal cell carcinoma (PRCC + CCRCC);

  • Cohort B: uveal melanoma (UM);

  • Cohort C: head and neck squamous cell carcinoma (HNSCC);

  • Cohort D: other cancers (non-RCC, non-UM and non-HNSCC); Part 1: Tumour c-MET positive membrane staining by immunohistochemistry (IHC)a and/or MET amplification by dual In Situ Hybridization (dISH)a and/or known MET-mutation; Part 2: Tumour c-MET positive membrane staining by immunohistochemistry (IHC) and MET-amplification by dual In Situ Hybridization (dISH), or tumour c-MET positive membrane staining by immunohistochemistry (IHC) and MET-mutation (excluding exon14m);

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
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

Sponsors and Collaborators

  • Byondis B.V.

Investigators

  • Study Director: Maaike Hendriks, Byondis B.V., The Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Byondis B.V.
ClinicalTrials.gov Identifier:
NCT05323045
Other Study ID Numbers:
  • BYON3521.001
First Posted:
Apr 12, 2022
Last Update Posted:
Aug 3, 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
Keywords provided by Byondis B.V.
ADC
c-MET
solid tumors

Study Results

No Results Posted as of Aug 3, 2022