Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

Sponsor

iTeos Belgium SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05289492

Collaborator

Bristol-Myers Squibb (Industry), GlaxoSmithKline (Industry), iTeos Therapeutics (Industry)

162

Enrollment

Locations

Arms

Anticipated Duration (Months)

40.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: EOS884448 Drug: Iberdomide Drug: Dexamethasone	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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
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 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 Drug: Iberdomide Iberdomide will be administered in arm B and C Other Names: CC-220 Drug: Dexamethasone Dexamethasone will be administered in arm C

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

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

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

Drug: Iberdomide

Iberdomide will be administered in arm B and C

Other Names:

CC-220

Drug: Dexamethasone

Dexamethasone will be administered in arm C

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
2	Institut Jules Bordet	Brussels		Belgium	1070
3	Universitaire Ziekenhuizen KU Leuven	Leuven		Belgium	3000
4	Centre Hospitalier Universitaire de Nantes	Nantes		France	44093