This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
EOS884448 will be administered in arm A,B and C
Iberdomide will be administered in arm B and C
Dexamethasone will be administered in arm C
Banner MD Anderson
Gilbert, Arizona, United States
Eastern Connecticut Hematology & Oncology
Norwich, Connecticut, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
Time frame: From first study treatment administration up to 120 days after the last dose
Number of participants with dose limiting toxicity (DLT)
Time frame: From first study treatment administration up to 120 days after the last dose
Recommended Phase 2 dose (RP2D) of EOS884448 alone or in combinations with iberdomide with or without dexamethasone in participants with relapse/refractory multiple myeloma
Time frame: up to 2 years
Number of participants with overall response (partial or better) as determined by IMWG criteria
Time frame: up to 2 years
Progression-free-survival (PFS)
Time frame: Until disease progression or death - Approximately 24 months
Duration of Response (DOR)
Time frame: Until disease progression or death - Approximately 24 months
Time to Response (TTR)
Time frame: Approximately 48 weeks
Maximum concentration (Cmax) of EOS884448 at each dose level
Time frame: Approximately 48 weeks
Percentage of participants with anti-drug antibodies to EOS884448
Time frame: Approximately 48 weeks
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Fred Hutchinson Cancer Center
Seattle, Washington, United States
ZNA Cadix
Antwerp, Belgium
Institut Jules Bordet
Brussels, Belgium
Universitaire Ziekenhuizen KU Leuven
Leuven, Belgium
CHU Amiens
Amiens, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
APHP Hôpital Saint-Antoine
Paris, France
...and 3 more locations