EICHORCondition: Acute Myeloid Leukemia · Myelodysplastic Syndromes · Sponsor: Chordia Therapeutics, Inc.
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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.
This description comes directly from the study's public registry record.
Laurie F Graham, RN, MSN · (609) 608-2152 · lgraham@theradex.com
Haris Durutlic · (781) 560-4419 · hdurutlic.chordia@gmail.com
Always discuss trial participation with your own doctor first.
| Mayo Clinic Arizona | Phoenix, Arizona, United States | Recruiting |
| Mayo Clinic Florida | Jacksonville, Florida, United States | Recruiting |
| Northwestern University | Chicago, Illinois, United States | Recruiting |
| Mayo Clinic Comprehensive Cancer Center | Rochester, Minnesota, United States | Recruiting |
| The University of Rochester | Rochester, New York, United States | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
| University of Virginia | Charlottesville, Virginia, United States | Recruiting |
| Fred Hutchinson Cancer Center | Seattle, Washington, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05732103