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Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
EOS884448
Iberdomide
Dexamethasone
Sponsored by
iTeos Belgium SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, iberdomide, CELMoD, CC-220, EOS-448

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hackensack University Medical CenterRecruiting
  • Institut Jules BordetRecruiting
  • Universitaire Ziekenhuizen KU LeuvenRecruiting
  • Centre Hospitalier Universitaire de NantesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A: Participants will receive EOS884448

B: Participants will receive EOS884448 and iberdomide

C: Participants will receive EOS884448, iberdomide and dexamethasone

Arm Description

EOS884448 will be administered

EOS884448 and iberdomide will be administered

EOS884448, iberdomide and dexamethasone will be administered

Outcomes

Primary Outcome Measures

Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
Number of participants with dose limiting toxicity (DLT)
Recommended Phase 2 dose (RP2D) of EOS884448 alone or in combinations with iberdomide with or without dexamethasone in participants with relapse/refractory multiple myeloma
Number of participants with overall response (partial or better) as determined by IMWG criteria

Secondary Outcome Measures

Progression-free-survival (PFS)
Duration of Response (DOR)
Time to Response (TTR)
Maximum concentration (Cmax) of EOS884448 at each dose level
Percentage of participants with anti-drug antibodies to EOS884448

Full Information

First Posted
March 11, 2022
Last Updated
July 10, 2023
Sponsor
iTeos Belgium SA
Collaborators
Bristol-Myers Squibb, GlaxoSmithKline, iTeos Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05289492
Brief Title
Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma
Official Title
Study of EOS884448 Alone, and in Combination With Iberdomide With or Without Dexamethasone, in Participants With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iTeos Belgium SA
Collaborators
Bristol-Myers Squibb, GlaxoSmithKline, iTeos Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, EOS884448, GSK4428859A, TIGIT, Anti-TIGIT, iberdomide, CELMoD, CC-220, EOS-448

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Participants will receive EOS884448
Arm Type
Experimental
Arm Description
EOS884448 will be administered
Arm Title
B: Participants will receive EOS884448 and iberdomide
Arm Type
Experimental
Arm Description
EOS884448 and iberdomide will be administered
Arm Title
C: Participants will receive EOS884448, iberdomide and dexamethasone
Arm Type
Experimental
Arm Description
EOS884448, iberdomide and dexamethasone will be administered
Intervention Type
Drug
Intervention Name(s)
EOS884448
Other Intervention Name(s)
EOS-448, GSK4428859A
Intervention Description
EOS884448 will be administered in arm A,B and C
Intervention Type
Drug
Intervention Name(s)
Iberdomide
Other Intervention Name(s)
CC-220
Intervention Description
Iberdomide will be administered in arm B and C
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered in arm C
Primary Outcome Measure Information:
Title
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
Title
Number of participants with dose limiting toxicity (DLT)
Time Frame
From first study treatment administration up to 120 days after the last dose
Title
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
Title
Number of participants with overall response (partial or better) as determined by IMWG criteria
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Progression-free-survival (PFS)
Time Frame
Until disease progression or death - Approximately 24 months
Title
Duration of Response (DOR)
Time Frame
Until disease progression or death - Approximately 24 months
Title
Time to Response (TTR)
Time Frame
Approximately 48 weeks
Title
Maximum concentration (Cmax) of EOS884448 at each dose level
Time Frame
Approximately 48 weeks
Title
Percentage of participants with anti-drug antibodies to EOS884448
Time Frame
Approximately 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
iTeos Belgium SA
Phone
+3271919933
Email
clinical_info@iteostherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iteos Clinical Trials
Organizational Affiliation
iTeos Belgium SA
Official's Role
Study Director
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David S. Siegel, MD, PhD
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie Meuleman, MD, PhD
Facility Name
Universitaire Ziekenhuizen KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Delforge, MD, Pr.
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Moreau, MD, Pr.

12. IPD Sharing Statement

Learn more about this trial

Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

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