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

Sponsor
Byondis B.V.
Study ID
NCT05737628
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BYON4228 + Rituximab — DRUG
    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.

Study Details

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

Key Dates

Start date
Mar 4, 2024
Status verified
Jan 2026
Primary completion
Feb 28, 2026
Completion
May 31, 2026

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BYON4228 + Rituximab

Primary Outcome Measure

Incidence of dose-limiting toxicities [ Time Frame: 28 days ]

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