A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Part of paid clinical trials in Duarte, California.

Sponsor
Crossbow Therapeutics, Inc.
Study ID
NCT06994676
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • AML - Acute Myeloid Leukemia
  • Chronic Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia (CMML)
  • High-risk Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CBX-250 — DRUG
    subcutaneous CBX-250

Study Details

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.

Key Dates

Start date
Jul 16, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CBX-250
    subcutaneous CBX-250

Primary Outcome Measure

To determine the safety, tolerability, RP2D, or MTD if different, and dosing regimen of CBX-250. [ Time Frame: Until the end of study (approximately 24 months) ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Mariah Santoscoy
[email protected]
626-218-2927
Brian Ball, MD (PRINCIPAL_INVESTIGATOR)
Stanford Medical CenterPalo AltoCalifornia94304
Gabriel Mannis, MD
[email protected]
Gabriel Mannis, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
David Sallman, MD (PRINCIPAL_INVESTIGATOR)
Northwestern MedicineChicagoIllinois60611
[email protected]
312-695-9367
Jessica Altman, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Megan Forsyth
[email protected]
857-215-1405
Evan Chen, MD (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63110
Morgan Swanner
[email protected]
314-454-8304
John DiPersio, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Eytan Stein, MD
[email protected]
Eytan Stein, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Elizabeth Waugh
[email protected]
267-408-7961
Gina Keiffer, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Cancer InstituteNashvilleTennessee37203
askSARAH
844-482-4812
Stephen Strickland, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Somedeb Ball, MD
[email protected]
615-322-8973
Somedeb Ball, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Ghayas Issa, MD
[email protected]
713-745-6798
Ghayas Issa, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAStanford Medical Center· Palo Alto, CAMoffitt Cancer Center· Tampa, FLNorthwestern Medicine· Chicago, ILDana Farber Cancer Institute· Boston, MAWashington University in St. Louis· St Louis, MO

Related Studies