Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05732103
PHASE1/PHASE2

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

Sponsor: Chordia Therapeutics, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

225

Start Date

2023-04-25

Completion Date

2029-02

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

CTX-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.

Locations (7)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Mayo Clinic Comprehensive Cancer Center

Rochester, Minnesota, United States

The University of Rochester

Rochester, New York, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States