Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT05289492
- Lead Sponsor
- iTeos Belgium SA
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
- All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).
- All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.
- All participants must have adequate organ function.
- Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.
- All participants with non-secretory MM
- All participants with known auto-immune disease
- All participants with history of life-threatening toxicity related to prior immune therapy.
- All participants with active graft versus host disease after allogeneic stem cell transplantation.
- All participants with active, unstable cardiovascular function.
- All participants with active infection requiring systemic therapy.
- All participants with hypersensitivity to any of the treatments.
- All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description B: Participants will receive EOS884448 and iberdomide EOS884448 EOS884448 and iberdomide will be administered C: Participants will receive EOS884448, iberdomide and dexamethasone EOS884448 EOS884448, iberdomide and dexamethasone will be administered A: Participants will receive EOS884448 EOS884448 EOS884448 will be administered C: Participants will receive EOS884448, iberdomide and dexamethasone Dexamethasone EOS884448, iberdomide and dexamethasone will be administered B: Participants will receive EOS884448 and iberdomide Iberdomide EOS884448 and iberdomide will be administered C: Participants will receive EOS884448, iberdomide and dexamethasone Iberdomide EOS884448, iberdomide and dexamethasone will be administered
- Primary Outcome Measures
Name Time Method Number of participants with overall response (partial or better) as determined by IMWG criteria up to 2 years Number of participants with any adverse events (AEs) and serious adverse events (SAEs) 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 up to 2 years Number of participants with dose limiting toxicity (DLT) From first study treatment administration up to 120 days after the last dose
- Secondary Outcome Measures
Name Time Method Time to Response (TTR) Approximately 48 weeks Maximum concentration (Cmax) of EOS884448 at each dose level Approximately 48 weeks Duration of Response (DOR) Until disease progression or death - Approximately 24 months Progression-free-survival (PFS) Until disease progression or death - Approximately 24 months Percentage of participants with anti-drug antibodies to EOS884448 Approximately 48 weeks
Trial Locations
- Locations (13)
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, United States
Eastern Connecticut Hematology & Oncology
🇺🇸Norwich, Connecticut, 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
CHU de Poitiers
🇫🇷Poitiers, France
APHP Hôpital Saint-Antoine
🇫🇷Paris, France
Hospital Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
CHU Toulouse
🇫🇷Toulouse, France
Banner MD Anderson
🇺🇸Gilbert, Arizona, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States