Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: A: Participants will receive EOS884448 EOS884448 will be administered |
Drug: EOS884448
EOS884448 will be administered in arm A,B and C
Other Names:
|
Experimental: B: Participants will receive EOS884448 and iberdomide EOS884448 and iberdomide will be administered |
Drug: EOS884448
EOS884448 will be administered in arm A,B and C
Other Names:
Drug: Iberdomide
Iberdomide will be administered in arm B and C
Other Names:
|
Experimental: C: Participants will receive EOS884448, iberdomide and dexamethasone EOS884448, iberdomide and dexamethasone will be administered |
Drug: EOS884448
EOS884448 will be administered in arm A,B and C
Other Names:
Drug: Iberdomide
Iberdomide will be administered in arm B and C
Other Names:
Drug: Dexamethasone
Dexamethasone will be administered in arm C
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Progression-free-survival (PFS) [Until disease progression or death - Approximately 24 months]
- 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]
- Percentage of participants with anti-drug antibodies to EOS884448 [Approximately 48 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
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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).
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All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.
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All participants must have adequate organ function.
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Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.
Exclusion Criteria:
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All participants with non-secretory MM
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All participants with known auto-immune disease
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All participants with history of life-threatening toxicity related to prior immune therapy.
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All participants with active graft versus host disease after allogeneic stem cell transplantation.
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All participants with active, unstable cardiovascular function.
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All participants with active infection requiring systemic therapy.
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All participants with hypersensitivity to any of the treatments.
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All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
2 | Institut Jules Bordet | Brussels | Belgium | 1070 | |
3 | Universitaire Ziekenhuizen KU Leuven | Leuven | Belgium | 3000 | |
4 | Centre Hospitalier Universitaire de Nantes | Nantes | France | 44093 |
Sponsors and Collaborators
- iTeos Belgium SA
- Bristol-Myers Squibb
- GlaxoSmithKline
- iTeos Therapeutics
Investigators
- Study Director: Iteos Clinical Trials, iTeos Belgium SA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TIG-007