At a glance
ClinicalIndex Comparison Record- ✓Age at least 18 years
- ✓Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (CMML); AML and HR-MDS only in expansion cohorts
- ✓1-4 prior lines of therapy (1-3 for expansion cohorts)
- ✓ECOG performance status ≤2
- ✕Acute promyelocytic leukemia (APL)
- ✕Active CNS leukemia
- ✕History of other malignancy
- ✕Myocardial infarction within 6 months prior to registration
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Multicenter, Open-Label Study of CTX-712 in Patients With Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
In Brief
A Phase 2 clinical trial evaluating CTX-712 for Acute Myeloid Leukemia and Myelodysplastic Syndromes. Currently recruiting, targeting 225 participants across 8 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.