Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

iTeos Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Iberdomide; Drug: EOS884448; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05289492

TIG-007

Details and patient eligibility

About

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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

16 participants in 3 patient groups

A: Participants will receive EOS884448

Experimental group

Description:

EOS884448 will be administered

Treatment:

Drug: EOS884448

B: Participants will receive EOS884448 and iberdomide

Experimental group

Description:

EOS884448 and iberdomide will be administered

Treatment:

Drug: EOS884448

Drug: Iberdomide

C: Participants will receive EOS884448, iberdomide and dexamethasone

Experimental group

Description:

EOS884448, iberdomide and dexamethasone will be administered

Treatment:

Drug: Dexamethasone

Drug: EOS884448

Drug: Iberdomide