A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Xaluritamig in Adult, Adolescent and Pediatric Participants With Relapsed or Refractory Ewing Sarcoma
Summary
The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric participants with relapsed or refractory EWS.
Arms & interventions
- DrugXaluritamig
Participants will receive xaluritamig via short-term intravenous (IV) infusion.
Outcome measures
Primary
Number of Participants Experiencing a Dose-limiting Toxicity (DLT) (Part 1 Only)
Time frame: Up to 42 days
Number of Participants with Treatment-emergent Adverse Events
This includes treatment-emergent, treatment-related, serious, and fatal adverse events. Any changes in safety assessments (vital signs and clinical laboratory tests) will be recorded as adverse events.
Time frame: Up to approximately 2.5 years
Secondary
Maximum Serum Concentration (Cmax) of Xaluritamig
Time frame: Up to approximately 6 months
Time to Cmax (tmax) of Xaluritamig
Time frame: Up to approximately 6 months
Minimum Serum Concentration (Cmin) of Xaluritamig
Time frame: Up to approximately 6 months
Accumulation Following Multiple Doses of Xaluritamig
Time frame: Up to approximately 6 months
Serum Concentration Before Dosing (Ctrough) of Xaluritamig
Time frame: Up to approximately 6 months
Half-life (t½) of Xaluritamig
Time frame: Up to approximately 6 months
Area Under the Serum Concentration-time Curve (AUC) of Xaluritamig
Time frame: Up to approximately 6 months
Confirmed Objective Response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 6 months
Disease Control per RECIST v1.1
Time frame: Up to approximately 6 months
Time to Response (TTR) per RECIST v1.1
Time frame: Up to approximately 6 months
Duration of Confirmed Response (DOR) per RECIST v1.1
Time frame: Up to approximately 6 months
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to approximately 6 months
Time to Progression (TTP) per RECIST v1.1
Time frame: Up to approximately 6 months
Time to First Subsequent Anti-cancer Therapy
Time frame: Up to approximately 6 months
Overall Survival (OS)
Time frame: Up to approximately 2 years
Number of Participants with Anti-xaluritamig Antibody Formation
Time frame: Up to approximately 6 months
Eligibility criteria
Study locations (4)
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of California Los Angeles
Los Angeles, California, 90995-1752
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Memorial Sloan Kettering Cancer Center
New York, New York, 10065