Acute Myeloid LeukemiaPhase 1/2NCT05732103
A Study of CTX-712 in Relapsed/Refractory Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndromes
A Phase 1/2 study testing CTX-712 in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Chordia Therapeutics, Inc. at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- CTX-712
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 8 sitesUnited States
- Study dates
- 25 Apr 2023to Feb 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML). Note: Only patients with AML and HR-MDS are eligible in the expansion cohorts.
- Prior treatment history must include 1-4 prior lines of therapy. Note: 1-3 prior lines are allowed for patients in the expansion cohorts.
- 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)
Show all 12Show fewer
- Alanine aminotransferase (ALT)
- Aspartate aminotransferase(AST) < 2.5 × ULN
- White blood cell count at the time of the first dose <10 k/μL
- Eastern Cooperative Oncology Group performance status ≤2.
- 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.
- 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.
Who cannot join
- Diagnosis of acute promyelocytic leukemia.
- Isolated extramedullary relapse (phase 2 only).
- Active central nervous system (CNS) leukemia.
- History of other malignancy.
- Any of the following cardiopulmonary abnormalities:
- Myocardial infarction within six months prior to registration.
Show all 18Show fewer
- New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction < 50%.
- A history of familial long QT syndrome.
- Symptomatic atrial or ventricular arrhythmias not controlled by medications.
- 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.
- Known moderate to severe and clinically significant chronic obstructive pulmonary disease, interstitial lung disease and/or pulmonary fibrosis (e.g., requiring home oxygen therapy).
- Pregnancy and/or lactation.
- Major surgery (excluding placement of vascular access) within 4 weeks prior to first dose of CTX-712.
- History of allogeneic organ transplantation (excluding cornea).
- 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.
- History of or chimeric antigen receptor T-cell therapy or other modified T cell therapy.
- 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.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Avani Hopkins, 434-243-8108, DRR3D@uvahealth.org
Daniel Reed, MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
RHLCCC Clinical Trial Line, 312-695-9367, cancer@northwestern.edu
Jessica Altman, MD
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Heather Schneider, 713-792-4478, hnschneider@mdanderson.org
Guillermo Garcia-Manero, MD
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015
James Foran, MD
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015
Cecilia A Yi, MD, MSHS
- Recruiting
Mayo Clinic Comprehensive Cancer Center
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015
Antoine Saliba, MD
- Recruiting
The University of Rochester
Rochester, New York, 14642
Jason Mendler, WCICTOResearch@URMC.Rochester.edu
Jason Mendler, MD, PhD
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Issac Miller, 206-606-1894, halpern2@uw.edu
Anna Halpern, MD
About this study
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
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
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- CTX-712
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX-712Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort | Experimental | 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 Receives: Drug: CTX-712 |
| Initial Expansion Cohort | Experimental | Drug: CTX-712 administered at a dose to be determined from the data of dose escalation cohort Receives: Drug: CTX-712 |
| Phase 2 | Experimental | CTX-712 administered at the recommended dose by the expansion cohort Receives: Drug: CTX-712 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712.
Measured: Adverse events are collected from time of informed consent through 28 days after last dose of CTX-712.
Phase 1: The maximum tolerated dose MTD.
MTD is the dose producing <33% of dose-limiting toxicities.
Measured: Dose-limiting toxicities are collected during the first treatment cycle (28 days).
Phase 2: Complete remission rate, defined as the proportion of patients who achieve complete remission.
Measured: Measured from date of first dose to 28 days after last dose of CTX-712.
Secondary outcomes (12)
Phase 1 and 2: Objective response rate, defined as the proportion of patients achieving a response.
For AML: CR, CRi, PR, MLFS. For MDS: CR, PR, mCR, HI.
Measured: Measured from date of first dose to 28 days after last dose of CTX-712.
Phase 1 and 2: Duration of response.
Measured: Measure from documentation of tumor response to disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Phase 1 and 2: Progression-free survival.
Measured: Measured from the date of initiating study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Phase 1 and 2: Overall survival.
Measured: Measured from the date of initiating study treatment to the date of death from any cause, assessed up to 36 months.
Phase 1 and 2: Proportion of patients who transition to hematopoietic stem cell transplantation (HSCT).
Measured: Measured from the date of the last administration of CTX-712 until HSCT, or one year from the date of the start of administration of CTX-712.
Phase 1: Maximum observed plasma concentration (Cmax) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Concentration before dose at steady state (Ctrough) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Pharmacokinetic evaluation performed in treatment Cycles 1, 2 and 4 (cycle duration is 28 days).
Phase 1: Area under the plasma concentration time curve (AUC) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Volume of distribution (Vd) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Elimination half-life of plasma concentration of CTX-712 at terminal phase (T1/2). Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Clearance (CL) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Measured: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Measurement of the change in RNA splicing by CTX-712 in peripheral blood samples as pharmacodynamic markers. Peripheral blood samples for PD analyses will be collected at predetermined time points and analyzed.
Measured: Pharmacodynamic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start25 Apr 2023
- Primary completionJun 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chordia Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theradex
- Responsible party
- Sponsor
- Investigators
- Guillermo Garcia-Manero, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732103
- Sponsor's protocol ID
- C22-11236
- Other IDs
- CTX-712-CL-02
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maron MI, Abdel-Wahab O. Outstanding Questions to Understand and Target Splicing Factor-Mutant Blood Cancers. Blood Cancer Discov. 2026 May 5;7(3):348-352. doi: 10.1158/2643-3230.BCD-26-0047.
PubMed 42013378Yokoyama 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 R, Miyake H, Yamamoto N. Phase 1 study of rogocekib in patients with relapsed or refractory hematologic malignancies. Blood Adv. 2026 Jan 13;10(1):262-272. doi: 10.1182/bloodadvances.2025017601.
PubMed 41056522
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05732103
- Acronym / sponsor ID
- C22-11236
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Chordia Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Theradex
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Drug: CTX-712Drug: 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 |
| Initial Expansion Cohort | Experimental | Drug: CTX-712Drug: CTX-712 administered at a dose to be determined from the data of dose escalation cohort |
| Phase 2 | Experimental | Drug: CTX-712CTX-712 administered at the recommended dose by the expansion cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years.
- Diagnosis of AML, HR-MDS, or high marrow blast MDS/MPN (including CMML). Note: Only patients with AML and HR-MDS are eligible in the expansion cohorts.
- Prior treatment history must include 1-4 prior lines of therapy. Note: 1-3 prior lines are allowed for patients in the expansion cohorts.
- Adequate organ function evidenced by the following laboratory values:
- Creatinine clearance (CL) ≥60 mL/min
Key exclusion criteria (18 listed)
- Diagnosis of acute promyelocytic leukemia.
- Isolated extramedullary relapse (phase 2 only).
- Active central nervous system (CNS) leukemia.
- History of other malignancy.
- Any of the following cardiopulmonary abnormalities:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX-712CTX-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. | Drug | Dose Escalation Cohort, Initial Expansion Cohort, Phase 2 |
Primary outcome
Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712.
Time frame: Adverse events are collected from time of informed consent through 28 days after last dose of CTX-712.
Phase 1: The maximum tolerated dose MTD.
Time frame: Dose-limiting toxicities are collected during the first treatment cycle (28 days).
MTD is the dose producing <33% of dose-limiting toxicities.
Phase 2: Complete remission rate, defined as the proportion of patients who achieve complete remission.
Time frame: Measured from date of first dose to 28 days after last dose of CTX-712.
12 secondary outcomes
Phase 1 and 2: Objective response rate, defined as the proportion of patients achieving a response.
Time frame: Measured from date of first dose to 28 days after last dose of CTX-712.
Phase 1 and 2: Duration of response.
Time frame: Measure from documentation of tumor response to disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Phase 1 and 2: Progression-free survival.
Time frame: Measured from the date of initiating study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to 24 months.
Phase 1 and 2: Overall survival.
Time frame: Measured from the date of initiating study treatment to the date of death from any cause, assessed up to 36 months.
Phase 1 and 2: Proportion of patients who transition to hematopoietic stem cell transplantation (HSCT).
Time frame: Measured from the date of the last administration of CTX-712 until HSCT, or one year from the date of the start of administration of CTX-712.
Phase 1: Maximum observed plasma concentration (Cmax) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Time frame: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Concentration before dose at steady state (Ctrough) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Time frame: Pharmacokinetic evaluation performed in treatment Cycles 1, 2 and 4 (cycle duration is 28 days).
Phase 1: Area under the plasma concentration time curve (AUC) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Time frame: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Volume of distribution (Vd) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Time frame: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Elimination half-life of plasma concentration of CTX-712 at terminal phase (T1/2). Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Time frame: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Clearance (CL) of CTX-712. Plasma samples for PK analyses will be collected at predetermined time points and analyzed.
Time frame: Pharmacokinetic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Phase 1: Measurement of the change in RNA splicing by CTX-712 in peripheral blood samples as pharmacodynamic markers. Peripheral blood samples for PD analyses will be collected at predetermined time points and analyzed.
Time frame: Pharmacodynamic evaluation performed in treatment Cycle 1 (cycle duration is 28 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42013378Maron MI, Abdel-Wahab O. Outstanding Questions to Understand and Target Splicing Factor-Mutant Blood Cancers. Blood Cancer Discov. 2026 May 5;7(3):348-352. doi: 10.1158/2643-3230.BCD-26-0047.
- Derived from this study: PubMed 41056522Yokoyama 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 R, Miyake H, Yamamoto N. Phase 1 study of rogocekib in patients with relapsed or refractory hematologic malignancies. Blood Adv. 2026 Jan 13;10(1):262-272. doi: 10.1182/bloodadvances.2025017601.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Garcia-Manero, MD principal investigator
M.D. Anderson Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CTX-712 in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by Chordia Therapeutics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie F Graham, RN, MSN ((609) 608-2152, lgraham@theradex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712. (time frame: Adverse events are collected from time of informed consent through 28 days after last dose of CTX-712.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05732103, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.