Clinical trial NCT05289492: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
EOS884448
GSK4428859A
TIGIT
Anti-TIGIT
iberdomide
CELMoD
CC-220
EOS-448
Belrestotug
Lead sponsor: iTeos Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: GlaxoSmithKline
name: iTeos Belgium SA
First posted: 2022-03-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
timeFrame: From first study treatment administration up to 120 days after the last dose
measure: Number of participants with dose limiting toxicity (DLT)
timeFrame: From first study treatment administration up to 120 days after the last dose
measure: Recommended Phase 2 dose (RP2D) of EOS884448 alone or in combinations with iberdomide with or without dexamethasone in participants with relapse/refractory multiple myeloma
timeFrame: up to 2 years
measure: Number of participants with overall response (partial or better) as determined by IMWG criteria
timeFrame: up to 2 years
Secondary outcomes:
measure: Progression-free-survival (PFS)
timeFrame: Until disease progression or death - Approximately 24 months
measure: Duration of Response (DOR)
timeFrame: Until disease progression or death - Approximately 24 months
measure: Time to Response (TTR)
timeFrame: Approximately 48 weeks
measure: Maximum concentration (Cmax) of EOS884448 at each dose level
timeFrame: Approximately 48 weeks
measure: Percentage of participants with anti-drug antibodies to EOS884448
timeFrame: Approximately 48 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson
state: Arizona
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology
state: Connecticut
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Antwerp
country: Belgium
facility: ZNA Cadix
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen KU Leuven
city: Amiens
country: France
facility: CHU Amiens
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: APHP Hôpital Saint-Antoine
city: Poitiers
country: France
facility: CHU de Poitiers
city: Toulouse
country: France
facility: CHU Toulouse
city: Madrid
country: Spain
facility: Hospital Fundacion Jimenez Diaz
Study officials:
affiliation: iTeos Belgium SA
name: Iteos Clinical Trials
role: STUDY_DIRECTOR
References: