A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
NCT ID: NCT05732103
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
225 participants
INTERVENTIONAL
2023-04-25
2029-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Cohort
Drug: CTX-712 administered at 20 mg, 40 mg, 80 mg, 100 mg, 140 mg weekly, or 60 mg, 80 mg, 100 mg twice a week
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.
Initial Expansion Cohort
Drug: CTX-712 administered at a dose to be determined from the data of dose escalation cohort
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.
Phase 2
CTX-712 administered at the recommended dose by the expansion cohort
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML).
3. Prior treatment history must include 1-4 prior lines of therapy.
4. Adequate organ function evidenced by the following laboratory values:
Creatinine clearance (CL) ≥60 mL/min Total serum bilirubin \< 1.5 × upper limit of normal (ULN) Alanine aminotransferase (ALT) Aspartate aminotransferase(AST) \< 2.5 × ULN White blood cell count at the time of the first dose \<10 k/μL
5. Eastern Cooperative Oncology Group performance status ≤2.
6. Female patients of childbearing potential must have a negative pregnancy test within 7 days before study treatment initiation and if sexually active, agree to use a highly effective form of contraception throughout their participation during study treatment and up to 4 months after the last dose of study drug
7. Male patients with female partners of childbearing potential must, even if surgically sterilized, agree to practice effective barrier contraception during the entire study treatment period and through four months after the last dose of study drug, or practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant.
Exclusion Criteria
2. Isolated extramedullary relapse (phase 2 only).
3. Active central nervous system (CNS) leukemia.
4. History of other malignancy.
5. Any of the following cardiopulmonary abnormalities:
1. Myocardial infarction within six months prior to registration.
2. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \< 50%.
3. A history of familial long QT syndrome.
4. Symptomatic atrial or ventricular arrhythmias not controlled by medications.
5. QTcF ≥ 470 msec calculated according to institutional guidelines, unless due to underlying bundle branch block and/or pacemaker and with approval of the medical monitor.
6. Known moderate to severe and clinically significant chronic obstructive pulmonary disease, interstitial lung disease and/or pulmonary fibrosis (e.g., requiring home oxygen therapy).
6. Pregnancy and/or lactation.
7. Major surgery (excluding placement of vascular access) within 4 weeks prior to first dose of CTX-712.
8. History of allogeneic organ transplantation (excluding cornea).
9. History of allogenic hematopoietic stem cell transplantation within 6 months of planned study treatment initiation and/or graft-versus host disease grade ≥ 1 following allogenic hematopoietic stem cell transplantation.
10. History of or chimeric antigen receptor T-cell therapy or other modified T cell therapy.
11. Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus, hepatitis C virus, known human immunodeficiency virus, or acquired immunodeficiency syndrome related illness. Infections controlled with oral anti-infective agents, including prophylactic treatments, are allowed. Patient must be viral load negative.
12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
18 Years
ALL
No
Sponsors
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Theradex
INDUSTRY
Chordia Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Guillermo Garcia-Manero, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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 Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
References
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Yokoyama H, Fukuhara N, Ando K, Iida H, Yamauchi T, Fukuhara S, Izutsu K, Tanoue Y, Yamamoto M, Tozaki H, Takahara E, Shoji S, Mizutani A, Morishita D, Oda RW, Miyake H, Yamamoto N. Phase I Study of Rogocekib in Patients with Relapsed or Refractory Hematologic Malignancies. Blood Adv. 2025 Oct 7:bloodadvances.2025017601. doi: 10.1182/bloodadvances.2025017601. Online ahead of print.
Other Identifiers
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CTX-712-CL-02
Identifier Type: OTHER
Identifier Source: secondary_id
C22-11236
Identifier Type: -
Identifier Source: org_study_id
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