CROSSCHECK-001: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias
Crossbow Therapeutics, Inc.
Summary
Study CBX-250-001 is a Phase 1, open-label, dose-escalation study of CBX-250 in participants with relapsed/refractory AML, HR-MDS, CMML, and CML. Participants aged ≥ 12 years are planned to be enrolled. CBX-250 will initially be investigated on a fixed step-up dosing schedule. CBX-250 will be administered subcutaneously in 28-day cycles, with the first study drug dose administered on Cycle 1, Day 1. Cycle 1 will consist of a priming phase over 7 days, and a target phase over 28 days. Participants will continue CBX-250 until progressive disease (PD) or unacceptable toxicity. All subsequent treatment cycles will be 28 days.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Dose Escalation: Male or female participants aged ≥18 years. 2. Backfill Cohorts: Male or female participants aged ≥12 years for whom no curative treatment options, including transplantation, are available. Diagnosis \& Disease Characteristics 3. Participants with histological confirmation of advanced hematologic malignancy including: 1. R/R AML, as defined by standardized criteria (e.g., European LeukemiaNet criteria \[Dohner 2022\]; after standard of care t…
Interventions
- DrugCBX-250
subcutaneous CBX-250
Locations (11)
- City of HopeDuarte, California
- Stanford Medical CenterPalo Alto, California
- Moffitt Cancer CenterTampa, Florida
- Northwestern MedicineChicago, Illinois
- Dana Farber Cancer InstituteBoston, Massachusetts
- Washington University in St. LouisSt Louis, Missouri