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A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
Sponsor: Chordia Therapeutics, Inc.
Summary
The goal of this phase 1/2 multicenter, open-label, single-arm dose escalation and expansion study is to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of CTX-712 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (HR-MDS), or MDS/MPN (including CMML). The phase 1 part of the study consists of sequential standard 3 + 3 dose escalation, where patients will receive ascending doses of CTX-712 to determine the recommended phase 2 dose (RP2D) for further clinical development. This is followed by initial expansion cohorts in AML and/or HR-MDS where patients will be treated with CTX-712 at the RP2D to gain further confidence in the selected dose level. Additional expansion cohorts may be initiated if considered necessary. After RP2D is determined, Drug-Drug-Interaction cohorts will be started. The phase 2 part of the study will commence after the RP2D has been identified and confirmed and will evaluate therapeutic activity in R/R AML or R/R HR-MDS, in addition to confirmation of the safety profile.
Official title: Phase 1/2 Multicenter, Open-Label Study of CTX-712 in Patients With Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
225
Start Date
2023-04-25
Completion Date
2029-02
Last Updated
2026-04-02
Healthy Volunteers
No
Interventions
CTX-712
CTX-712 will be provided as a 20 mg tablet for oral administration. Patients will take CTX-712 once or twice weekly, depending on their dose level assignment, during each 28-day cycle.
Locations (7)
Mayo Clinic Arizona
Phoenix, Arizona, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, United States
The University of Rochester
Rochester, New York, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States