RecruitingPhase 1Phase 2NCT05732103

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

Phase 1/2 Multicenter, Open-Label Study of CTX-712 in Patients With Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes

Sponsor

Chordia Therapeutics, Inc.

Enrollment

225 participants

Start Date

Apr 25, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new drug called CTX-712 in people with relapsed or treatment-resistant acute myeloid leukaemia (AML) or high-risk myelodysplastic syndromes (MDS) — blood and bone marrow cancers that have stopped responding to standard treatments. The goal is to find a safe dose and see whether CTX-712 can help control or shrink the cancer. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with AML, high-risk MDS, or a related blood cancer - You have received 1 to 4 prior treatments for your cancer - Your organs (kidneys, liver) are functioning well enough - You are in reasonably good health and can carry out some daily activities **You may NOT be eligible if...** - You have acute promyelocytic leukaemia (a specific subtype of AML) - You have active leukaemia in the brain or spinal fluid - You have had a heart attack in the last 6 months, or have severe heart failure - You have had a stem cell transplant from a donor within the last 6 months - You have an active, uncontrolled infection (including HIV, hepatitis B or C) - You are pregnant or breastfeeding - You have had major surgery in the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCTX-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.