Overview

Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
iTeos Belgium SA
Collaborators:
Bristol-Myers Squibb
GlaxoSmithKline
iTeos Therapeutics
Treatments:
Dexamethasone
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.