A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes

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 ex

Trial Details

NCT ID
NCT05732103
Phase
PHASE1 / PHASE2
Sponsor
Chordia Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • CTX-712
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Rochester, New York, United States|43.15478,-77.61556

Key Eligibility Criteria

  • Age ≥18 years.
  • Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML). Note: Only patients with AML and HR-MDS are eligible in the expansion coho…
  • Prior treatment history must include 1-4 prior lines of therapy. Note: 1-3 prior lines are allowed for patients in the expansion cohorts.
  • Adequate organ function evidenced by the following laboratory values:

For full eligibility, visit ClinicalTrials.gov.

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