This is the first-in-human study with BYON4228, a humanized monoclonal antibody (mAb) directed against SIRPα.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
BYON4228 is a humanized monoclonal antibody (mAb) directed against SIRPα. BYON4228 IV infusion every four weeks until disease progression or unacceptable toxicity. Different doses. Rituximab IV infusion (375 mg/m2) starting from the second treatment cycle onwards. Weekly infusion during the first cycle and every four weeks in subsequent 5 cycles.
ASST Spedali Civili di Brescia
Brescia, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Italy
Instituto Europeo di Oncologia
Milan, Italy
Incidence of dose-limiting toxicities
Part 1
Time frame: 28 days
Objective response rate
Part 2
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IRCCS Ospedale San Raffaele
Milan, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS IRST
Ravenna, Italy
Vrije Universiteit Medisch Centrum
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
...and 2 more locations