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Spots Global Cancer Trial Database for First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228

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Trial Identification

Brief Title: First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228

Official Title: First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination With Rituximab to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Relapsed/Refractory CD20 Positive B-cell Non-Hodgkin's Lymphoma (NHL)

Study ID: NCT05737628

Conditions

Lymphoma

Study Description

Brief Summary: This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.

Detailed Description: This study includes a dose escalation part (Part 1) in which the MTD and dose regimen for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts. BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

ASST Spedali Civili di Brescia, Brescia, , Italy

Amsterdam Universitair Medisch Centrum locatie VUmc, Amsterdam, , Netherlands

Radboud UMC, Nijmegen, , Netherlands

Hospital Universitari Vall d'Hebron, Barcelona, , Spain

Institut Català d'Oncologia, Barcelona, , Spain

Centro Integral Oncológico Clara Campal (CIOCC) Hospital Universitario HM Sanchinarro, Madrid, , Spain

The Christie NHS Foundation Trust, Manchester, , United Kingdom

Derriford Hospital, Plymouth, , United Kingdom

Contact Details

Name: Willem Klaassen

Affiliation: Byondis B.V., The Netherlands

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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