Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, iberdomide, CELMoD, CC-220, EOS-448, Belrestotug
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).
Interventions
DRUGEOS884448
EOS884448 will be administered in arm A,B and C
DRUGIberdomide
Iberdomide will be administered in arm B and C
DRUGDexamethasone
Dexamethasone will be administered in arm C
Sponsors
Bristol-Myers Squibb
GlaxoSmithKline
iTeos Belgium SA
iTeos Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Number of participants with dose limiting toxicity (DLT) | 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 overall response (partial or better) as determined by IMWG criteria | up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free-survival (PFS) | Until disease progression or death - Approximately 24 months |
| Percentage of participants with anti-drug antibodies to EOS884448 | Approximately 48 weeks |
| Duration of Response (DOR) | Until disease progression or death - Approximately 24 months |
| Time to Response (TTR) | Approximately 48 weeks |
| Maximum concentration (Cmax) of EOS884448 at each dose level | Approximately 48 weeks |
Countries
Belgium, France, Spain, United States
Outcome results
None listed