Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05289492
• Other study ID #: TIG-007
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 1, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: March 2024
• Source: iTeos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• EOS884448
EOS884448 will be administered in arm A,B and C
• Iberdomide
Iberdomide will be administered in arm B and C
• Dexamethasone
Dexamethasone will be administered in arm C

Locations

Country	Name	City	State
Belgium	ZNA Cadix	Antwerp
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitaire Ziekenhuizen KU Leuven	Leuven
France	CHU Amiens	Amiens
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	APHP Hôpital Saint-Antoine	Paris
France	CHU de Poitiers	Poitiers
France	CHU Toulouse	Toulouse
Spain	Hospital Fundacion Jimenez Diaz	Madrid
United States	Banner MD Anderson	Gilbert	Arizona
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Eastern Connecticut Hematology & Oncology	Norwich	Connecticut
United States	Fred Hutchinson Cancer Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
iTeos Belgium SA	Bristol-Myers Squibb, GlaxoSmithKline, iTeos Therapeutics

Countries where clinical trial is conducted

United States,  Belgium,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants with dose limiting toxicity (DLT)		From first study treatment administration up to 120 days after the last dose
Primary	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
Primary	Number of participants with overall response (partial or better) as determined by IMWG criteria		up to 2 years
Secondary	Progression-free-survival (PFS)		Until disease progression or death - Approximately 24 months
Secondary	Duration of Response (DOR)		Until disease progression or death - Approximately 24 months
Secondary	Time to Response (TTR)		Approximately 48 weeks
Secondary	Maximum concentration (Cmax) of EOS884448 at each dose level		Approximately 48 weeks
Secondary	Percentage of participants with anti-drug antibodies to EOS884448		Approximately 48 weeks