Status:
TERMINATED
Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
iTeos Therapeutics
Collaborating Sponsors:
Bristol-Myers Squibb
GlaxoSmithKline
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 GSK44...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05289492
Start Date
May 1 2022
End Date
November 29 2023
Last Update
October 26 2024
Active Locations (13)
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1
Banner MD Anderson
Gilbert, Arizona, United States, 85234
2
Eastern Connecticut Hematology & Oncology
Norwich, Connecticut, United States, 06360
3
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
4
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109