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Company operational decision. Decision to stop study is not due to safety or efficacy concerns
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
| iTeos Belgium SA | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Participants will receive EOS884448 | Experimental | EOS884448 will be administered |
|
| B: Participants will receive EOS884448 and iberdomide | Experimental | EOS884448 and iberdomide will be administered |
|
| C: Participants will receive EOS884448, iberdomide and dexamethasone | Experimental | EOS884448, iberdomide and dexamethasone will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOS884448 | Drug | EOS884448 will be administered in arm A,B and C |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free-survival (PFS) | Until disease progression or death - Approximately 24 months | |
| Duration of Response (DOR) | Until disease progression or death - Approximately 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iteos Clinical Trials | iTeos Belgium SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson | Gilbert | Arizona | 85234 | United States | ||
| Eastern Connecticut Hematology & Oncology |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| C000624220 | iberdomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Iberdomide | Drug | Iberdomide will be administered in arm B and C |
|
|
| Dexamethasone | Drug | Dexamethasone will be administered in arm C |
|
| 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 |
| Norwich |
| Connecticut |
| 06360 |
| United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| ZNA Cadix | Antwerp | 2020 | Belgium |
| Institut Jules Bordet | Brussels | 1070 | Belgium |
| Universitaire Ziekenhuizen KU Leuven | Leuven | 3000 | Belgium |
| CHU Amiens | Amiens | 80054 | France |
| Centre Hospitalier Universitaire de Nantes | Nantes | 44093 | France |
| APHP Hôpital Saint-Antoine | Paris | 75012 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| CHU Toulouse | Toulouse | 31059 | France |
| Hospital Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |