Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

October 23, 2024 updated by: iTeos Therapeutics

Study of EOS884448 Alone, and in Combination with Iberdomide with or Without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • ZNA Cadix
      • Brussels, Belgium, 1070
        • Institut Jules Bordet
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen KU Leuven
  • France
      • Amiens, France, 80054
        • CHU AMIENS
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire de Nantes
      • Paris, France, 75012
        • APHP Hopital Saint-Antoine
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Toulouse, France, 31059
        • CHU Toulouse
  • Spain
      • Madrid, Spain, 28040
        • Hospital Fundación Jiménez Díaz
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology & Oncology
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • EOS-448, GSK4428859A, Belrestotug
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:
  • EOS-448, GSK4428859A, Belrestotug
Drug: Iberdomide
Iberdomide will be administered in arm B and C
Other Names:
  • CC-220
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:
  • EOS-448, GSK4428859A, Belrestotug
Drug: Iberdomide
Iberdomide will be administered in arm B and C
Other Names:
  • CC-220
Drug: Dexamethasone
Dexamethasone will be administered in arm C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From first study treatment administration up to 120 days after the last dose
Number of participants with dose limiting toxicity (DLT)
Time Frame: From first study treatment administration up to 120 days after the last dose
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
Time Frame: up to 2 years
up to 2 years
Number of participants with overall response (partial or better) as determined by IMWG criteria
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free-survival (PFS)
Time Frame: Until disease progression or death - Approximately 24 months
Until disease progression or death - Approximately 24 months
Duration of Response (DOR)
Time Frame: Until disease progression or death - Approximately 24 months
Until disease progression or death - Approximately 24 months
Time to Response (TTR)
Time Frame: Approximately 48 weeks
Approximately 48 weeks
Maximum concentration (Cmax) of EOS884448 at each dose level
Time Frame: Approximately 48 weeks
Approximately 48 weeks
Percentage of participants with anti-drug antibodies to EOS884448
Time Frame: Approximately 48 weeks
Approximately 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iTeos Therapeutics

Collaborators

Bristol-Myers Squibb
GlaxoSmithKline
iTeos Belgium SA

Investigators

  • Study Director: Iteos Clinical Trials, iTeos Belgium SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

November 29, 2023

Study Completion (Actual)

November 29, 2023

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIG-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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