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TerminatedNCT05289492Updated Oct 26, 2024

Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

A Phase 1 interventional study of EOS884448 and Iberdomide in Multiple Myeloma, sponsored by iTeos Therapeutics. Terminated at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by iTeos Therapeutics · Phase 1, Interventional, and Treatment

Why this study was terminated
Company operational decision. Decision to stop study is not due to safety or efficacy concerns

From the registry’s dates

  • Primary completion was Nov 2023, 2 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Multiple Myeloma
  • EOS884448
  • GSK4428859A
  • TIGIT
  • Anti-TIGIT
  • iberdomide
  • CELMoD
  • CC-220
  • EOS-448
  • Belrestotug
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 16 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

iTeos Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    A: Participants will receive EOS884448

    EOS884448 will be administered

    Drug: EOS884448

  • Experimental
    B: Participants will receive EOS884448 and iberdomide

    EOS884448 and iberdomide will be administered

    Drug: EOS884448 · Drug: Iberdomide

  • Experimental
    C: Participants will receive EOS884448, iberdomide and dexamethasone

    EOS884448, iberdomide and dexamethasone will be administered

    Drug: EOS884448 · Drug: Iberdomide · Drug: Dexamethasone

Interventions

  • DrugEOS884448

    EOS884448 will be administered in arm A,B and C

    Also known as: EOS-448, GSK4428859A, Belrestotug

  • DrugIberdomide

    Iberdomide will be administered in arm B and C

    Also known as: CC-220

  • DrugDexamethasone

    Dexamethasone will be administered in arm C

06

What researchers measure

Primary outcomes

  1. 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

  2. Number of participants with dose limiting toxicity (DLT)

    Time frame: From first study treatment administration up to 120 days after the last dose

  3. 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

  4. Number of participants with overall response (partial or better) as determined by IMWG criteria

    Time frame: up to 2 years

Secondary outcomes

  1. Progression-free-survival (PFS)

    Time frame: Until disease progression or death - Approximately 24 months

  2. Duration of Response (DOR)

    Time frame: Until disease progression or death - Approximately 24 months

  3. Time to Response (TTR)

    Time frame: Approximately 48 weeks

  4. Maximum concentration (Cmax) of EOS884448 at each dose level

    Time frame: Approximately 48 weeks

  5. Percentage of participants with anti-drug antibodies to EOS884448

    Time frame: Approximately 48 weeks

07

Study locations

13 sites
  • Banner MD Anderson
    Gilbert, Arizona 85234, United States
  • Eastern Connecticut Hematology & Oncology
    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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05289492
Lead sponsor
iTeos Therapeutics
Collaborators
Bristol-Myers Squibb, GlaxoSmithKline, iTeos Belgium SA
Responsible party
Sponsor
First posted
Mar 21, 2022
Start date
May 1, 2022
Primary completion
Nov 29, 2023
Completion
Nov 29, 2023
Last update
Oct 26, 2024

Study contacts

Iteos Clinical Trials
study director · iTeos Belgium SA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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