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NCT05732103 · ClinicalTrials.gov registry record · Phase 1
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Chordia Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 225
- Enrollment target
- 7
- Study locations
NCT05732103: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Chordia Therapeutics.
NCT05732103 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Chordia Therapeutics. The registered enrollment target is 225 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (96% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05732103, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Chordia Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 225 participants
- Enrollment target
- 7
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG CTX-712
Study Locations (7)
Arizona
- Mayo Clinic Arizona - Phoenix
Florida
- Mayo Clinic Florida - Jacksonville
Minnesota
- Mayo Clinic Comprehensive Cancer Center - Rochester
New York
- The University of Rochester - Rochester
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Virginia
- University of Virginia - Charlottesville
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2023-04-25 |
| Est. Completion | 2029-02 |
| Phase | Phase 1 |
What NCT05732103 shows while recruiting
NCT05732103 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (96% higher).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CTX-712 is the first listed.
NCT05732103 lists 7 locations in 7 states (Arizona, Florida, Minnesota).
Frequently Asked Questions
What is clinical trial NCT05732103 about?
NCT05732103 is a clinical study titled "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 syn...
What is the current status of trial NCT05732103?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 225 participants. The study started on 2023-04-25. Estimated completion is 2029-02.
What conditions does trial NCT05732103 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT05732103?
The interventions under investigation include: CTX-712 (DRUG).
Who is sponsoring clinical trial NCT05732103?
This trial is sponsored by Chordia Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05732103 being conducted?
This trial has 7 study locations across Arizona, Florida, Minnesota, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05732103's enrollment target sits among peer trials
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