Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

NCT05289492 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: TIG-007
• Study Type: interventional
• Target: 16
• Locations: 4 countries
• Sites: 13

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).

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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

Study Arms (3)

A: Participants will receive EOS884448

EXPERIMENTAL

EOS884448 will be administered

Drug: EOS884448

B: Participants will receive EOS884448 and iberdomide

EXPERIMENTAL

EOS884448 and iberdomide will be administered

Drug: EOS884448; Drug: Iberdomide

C: Participants will receive EOS884448, iberdomide and dexamethasone

EXPERIMENTAL

EOS884448, iberdomide and dexamethasone will be administered

Drug: EOS884448; Drug: Iberdomide; Drug: Dexamethasone

Interventions

EOS884448 DRUG

EOS884448 will be administered in arm A,B and C

Also known as: EOS-448, GSK4428859A, Belrestotug

A: Participants will receive EOS884448; B: Participants will receive EOS884448 and iberdomide; C: Participants will receive EOS884448, iberdomide and dexamethasone

Iberdomide DRUG

Iberdomide will be administered in arm B and C

Also known as: CC-220

B: Participants will receive EOS884448 and iberdomide; C: Participants will receive EOS884448, iberdomide and dexamethasone

Dexamethasone DRUG

Dexamethasone will be administered in arm C

C: Participants will receive EOS884448, iberdomide and dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iTeos Therapeutics: lead
• Bristol-Myers Squibb: collaborator
• GlaxoSmithKline: collaborator
• iTeos Belgium SA: collaborator

Study Sites (13)

Banner MD Anderson

Gilbert, Arizona, 85234, United States

Location

Eastern Connecticut Hematology & Oncology

Norwich, Connecticut, 06360, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

ZNA Cadix

Antwerp, 2020, Belgium

Location

Institut Jules Bordet

Brussels, 1070, Belgium

Location

Universitaire Ziekenhuizen KU Leuven

Leuven, 3000, Belgium

Location

CHU Amiens

Amiens, 80054, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

Location

APHP Hôpital Saint-Antoine

Paris, 75012, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Hospital Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

iberdomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Iteos Clinical Trials

  iTeos Belgium SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: May 1, 2022
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

BE (3); FR (5); ES (1); US (4)