Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression (MOMENTUM)

July 17, 2026 updated by: AstraZeneca

A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression

The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a first in human (FTiH), open-label, multi-centre study of AZD3632 in participants with relapsed or refractory acute leukaemia or myelodysplastic Syndromes (MDS) with HOX overexpression genotypes.

This study includes multiple modules (module 1 and module 2) each investigating AZD3632 in a specific population and/or in combination with other anticancer agents.

Module 1 is a dose escalation of AZD3632 monotherapy. Module 2 will investigate the safety, PK, and tolerability when co-administered with posaconazole.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Fitzroy, Australia, 3065
        • Suspended
        • Research Site
      • Perth, Australia, WA 6000
        • Suspended
        • Research Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Suspended
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Suspended
        • Research Site
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Research Site
  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Research Site
      • Frankfurt A. Main, Germany, 60590
        • Recruiting
        • Research Site
      • Halle, Germany, 06097
        • Recruiting
        • Research Site
      • Heidelberg, Germany, 69120
        • Recruiting
        • Research Site
      • München, Germany, 81377
        • Recruiting
        • Research Site
      • Ulm, Germany, 89081
        • Recruiting
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Research Site
      • Ravenna, Italy, 48121
        • Recruiting
        • Research Site
  • Japan
      • Bunkyō City, Japan, 113-8677
        • Recruiting
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Not yet recruiting
        • Research Site
      • Okayama, Japan, 700-8558
        • Recruiting
        • Research Site
  • South Korea
      • Seoul, South Korea, 06351
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Research Site
      • Seoul, South Korea, 110-744
        • Recruiting
        • Research Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • Research Site
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Research Site
      • Newcastle, United Kingdom, NE7 7DN
        • Suspended
        • Research Site
  • United States
    • Illinois
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Not yet recruiting
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • Research Site
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Suspended
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

Core criteria:

  • Adequate organ function.
  • Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Module 1:

  • Advanced haematologic malignancy - a) for dose escalation - diagnosis of acute leukemia or myelodysplastic neoplasia (MDS) and harbouring one of the genetic alterations per local testing associated with upregulation of HOX; b) for Backfill - diagnosis of harbouring a KMT2Ar or NPM1m per local testing.
  • Participants must have measurable disease that is relapsed/refractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory acute leukaemia after standard of care therapy including but not limited to 2 cycles of intensive chemotherapy, hypomethylating agent (HMA) monotherapy, or HMA combinations such as HMA/venetoclax.; b) Relapsed and primary refractory MDS is defined by ≥ 5% blasts in the bone marrow and/or persistence of peripheral blasts after treatment with at least 2 cycles of HMA. Participants ineligible for the treatment with an HMA and without any other standard of care (SoC) options are allowed to enrol; c) White blood cell count below 25,000/μL. Participants may receive cytoreduction per protocol-specified criteria; d) Performance status: Eastern Cooperative Operative Group (ECOG) ≤ 2; e) Life expectancy: ≥ 8 weeks.

Module 2:

  • Participants must have measurable disease that is relapsed/refractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory acute leukaemia after standard of care therapy including but not limited to 2 cycles of intensive chemotherapy, HMA monotherapy, or HMA combinations such as HMA/venetoclax.; b) Relapsed and primary refractory MDS is defined by ≥ 5% blasts in the bone marrow and/or persistence of peripheral blasts after treatment with at least 2 cycles of HMA. Participants ineligible for the treatment with an HMA and without any other SoC options are allowed to enrol; c) White blood cell count below 25,000/μL. Participants may receive cytoreduction per protocol-specified criteria; d) Performance status: ECOG ≤ 2; e) Life expectancy: ≥ 8 weeks.

Key Exclusion Criteria:

Core criteria:

  • Participants with Burkitt lymphoma/leukaemia or Acute Promyelocytic Leukaemia.
  • Active testicular or active central nervous system (CNS) (> CNS1 or radiographic) involvement by leukaemia.
  • Unresolved treatment-related toxicities Grade ≥ 2 from prior therapy.
  • Abnormal levels of potassium or magnesium prior to first dose of AZD3632.

Module 1:

  • Receipt of non-CNS radiation therapy within 2 weeks and of CNS radiation within 8 weeks of the first scheduled dose.
  • Receipt of any investigational or non-investigational anticancer agents, including non-biologic agents, biologic agents and/or prior treatment other menin inhibitors (backfill participants only).
  • For nested food effect participants - diagnosis of diabetes mellitus (Type I or Type II).

Module 2:

  • Receipt of any non-investigational anticancer agents, including non-biologic agents and/or biologic agents or receipt of non-CNS or CNS radiation therapy.
  • Participants for whom treatment with posaconazole is contraindicated per the local prescribing information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Module 1: AZD3632 dose 1
Participants will receive AZD3632 (dose 1) through the treatment period.
Drug: AZD3632
AZD3632 will be administered orally.
Experimental: Module 1: AZD3632 dose 2
Participants will receive AZD3632 (dose 2) through the treatment period.
Drug: AZD3632
AZD3632 will be administered orally.
Experimental: Module 1: AZD3632 dose 3
Participants will receive AZD3632 (dose 3) through the treatment period.
Drug: AZD3632
AZD3632 will be administered orally.
Experimental: Module 1: AZD3632 dose 4
Participants will receive AZD3632 (dose 4) through the treatment period.
Drug: AZD3632
AZD3632 will be administered orally.
Experimental: Module 1: AZD3632 dose 5
Participants will receive AZD3632 (dose 5) through the treatment period.
Drug: AZD3632
AZD3632 will be administered orally.
Experimental: Module 1: AZD3632 dose 6
Participants will receive AZD3632 (dose 6) through the treatment period.
Drug: AZD3632
AZD3632 will be administered orally.
Experimental: Module 2: AZD3632 + posaconazole
Participants will receive AZD3632 alone, then will receive AZD3632 in combination with posaconazole through treatment period.
Drug: AZD3632
AZD3632 will be administered orally.
Drug: Posaconazole
Posaconazole will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Module 1: Number of participants with dose-limiting toxicity (DLT)
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.
At the end of Cycle 1 (each cycle is 28 days)
Module 1 and Module 2: Number of participants with dose modification, delay and discontinuations due to adverse events (AEs)
Time Frame: Up to 3 years 1 month
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed.
Up to 3 years 1 month
Module 1 and Module 2: Number of participants with treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs) and serious adverse vents (SAEs)
Time Frame: Up to 30 days after last dose (approximately 3 years 1 month)
Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed. Adverse events will be defined as treatment-emergent if they have an onset or worsen (by investigator report of a change in intensity) during the study treatment or the safety follow-up period but prior to any subsequent cancer therapy.
Up to 30 days after last dose (approximately 3 years 1 month)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Module 1 and Module 2: Maximum concentration (Cmax) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy (module 1) and in combination with posaconazole (module 2) will be assessed.
From Day 1 to 3 years 1 month
Module 1 and Module 2: Time of maximum concentration (Tmax) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy (module 1) and in combination with posaconazole (module 2) will be assessed.
From Day 1 to 3 years 1 month
Module 1: Trough concentration (Ctrough) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
From Day 1 to 3 years 1 month
Module 1: Area under the plasma concentration-time Curve from Time Zero to Infinity (AUC[inf]) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
From Day 1 to 3 years 1 month
Module 1 and Module 2: Area under the curve from time 0 to the time of last measurable concentration (AUC[0-t]) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy (module 1) and in combination with posaconazole (module 2) will be assessed.
From Day 1 to 3 years 1 month
Module 1: Area under concentration-time curve in the dosing interval (AUCtau) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
From Day 1 to 3 years 1 month
Module 1: Apparent total body clearance (CL/F) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
From Day 1 to 3 years 1 month
Module 1: Apparent volume of distribution based on the terminal phase (VZ/F) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
From Day 1 to 3 years 1 month
Module 1: Half-life (t1/2) of AZD3632
Time Frame: From Day 1 to 3 years 1 month
The PK of AZD3632 as monotherapy will be assessed.
From Day 1 to 3 years 1 month
Module 1: Maximum concentration (Cmax) of AZD3632 (food effect)
Time Frame: From Day 1 to 3 years 1 month
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
From Day 1 to 3 years 1 month
Module 1: Time of maximum concentration (Tmax) of AZD3632 (food effect)
Time Frame: From Day 1 to 3 years 1 month
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
From Day 1 to 3 years 1 month
Module 1 and Module 2: Area under the curve from time 0 to the time of last measurable concentration (AUC[0-t]) of AZD3632 (food effect)
Time Frame: From Day 1 to 3 years 1 month
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
From Day 1 to 3 years 1 month
Module 1: Area under concentration-time curve in the dosing interval (AUCtau) of AZD3632 (food effect)
Time Frame: From Day 1 to 3 years 1 month
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
From Day 1 to 3 years 1 month
Module 1: Minimum concentration (Cmin) of AZD3632 (food effect)
Time Frame: From Day 1 to 3 years 1 month
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
From Day 1 to 3 years 1 month
Module 1: Ratio of Cmax between fed and fasted state
Time Frame: From Day 1 to 3 years 1 month
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
From Day 1 to 3 years 1 month
Module 1: Ratio of AUC(0-t) between fed and fasted state
Time Frame: From Day 1 to 3 years 1 month
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
From Day 1 to 3 years 1 month
Module 1: Ratio of AUCtau between fed and fasted state
Time Frame: From Day 1 to 3 years 1 month
The preliminary effect of food on plasma PK of AZD3632 (conducted in a nested evaluation during backfills) will be assessed.
From Day 1 to 3 years 1 month
Module 2: Plasma geometric mean ratio of Cmax
Time Frame: From Day 1 to 3 years 1 month
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
From Day 1 to 3 years 1 month
Module 2: Plasma geometric mean ratio of AUC
Time Frame: From Day 1 to 3 years 1 month
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
From Day 1 to 3 years 1 month
Module 2: Plasma concentration of posaconazole
Time Frame: From Day 1 to 3 years 1 month
The PK pf AZD3632 when co-administered with posaconazole will be assessed.
From Day 1 to 3 years 1 month
Module 1 and Module 2: Complete response rate (CR + CRh)
Time Frame: Up to 3 years 1 month
Complete response rate is defined as the percentage of participants who have a complete remission (CR) or complete remission with partial haematological recovery (CRh) as assessed by the investigator at local site.
Up to 3 years 1 month
Module 1 and Module 2: Time to response (TTR)
Time Frame: Up to 3 years 1 month

TTR in participants with acute leukaemia is defined as the time from date of first dose until date of first documented complete response (CR/CRh) among participants with acute leukaemia in the Response Evaluable Set who achieved complete response as assessed by investigator at local site.

TTR in participants with MDS is defined as the time from date of first dose until date of first documented objective response a CR (or CR equivalent), complete response with limited count recovery [CRL], CRh, partial response [PR], or haematologic improvement [HI]) among participants with MDS in the Response Evaluable Set who achieved objective response as assessed by investigator at local site.
Up to 3 years 1 month
Module 1 and Module 2: Duration of response (DoR)
Time Frame: Up to 3 years 1 month

DoR in participants with acute leukaemia is defined as the time from date of first documented complete response (CR/CRh) until date of first documented relapse or death (by any cause in the absence of relapse) as assessed by investigator at local site.

DoR in participants with MDS is defined as the time from date of first documented objective response CR (or CR equivalent), CRL, CRh, PR, or HI until date of first documented relapse or death (by any cause in the absence of relapse) as assessed by investigator at local site.
Up to 3 years 1 month
Module 1 and Module 2: Transfusion Independence (TI)
Time Frame: Up to 3 years 1 month
TI is defined as no RBC and no platelet transfusion during any consecutive period of at least 56 days post-baseline after starting treatment with AZD3632 or cessation of treatment with AZD3632 but prior to start of subsequent new therapy.
Up to 3 years 1 month
Module 1 and Module 2: Event-free Survival (EFS)
Time Frame: From Cycle 2 Day 1 (each cycle is 28 days) up to disease follow-up (approximately 3 years 1 month)

EFS for participants with acute leukaemia is defined as the time from date of first dose until date of relapse, progressive disease, failure to achieve at least Morphologic leukaemia-free state (MLFS) by end of Cycle 6, or death due to any cause as assessed by investigator at a local site.

EFS for participants with MDS is defined as the time from date of first dose until date of relapse, progressive disease, failure to achieve at least HI by end of Cycle 6, or death due to any cause.
From Cycle 2 Day 1 (each cycle is 28 days) up to disease follow-up (approximately 3 years 1 month)
Module 1 and Module 2: Overall Survival (OS)
Time Frame: From Cycle 2 Day 1 (each cycle is 28 days) up to disease follow-up (approximately 3 years 1 month)
OS is defined as the time from date of first dose until date of death due to any cause regardless of whether the participant withdraws from study therapy or receives another anticancer therapy.
From Cycle 2 Day 1 (each cycle is 28 days) up to disease follow-up (approximately 3 years 1 month)
Module 1 and Module 2: Percentage of participants who receive subsequent allogeneic hematopoietic stem cell transplant (HSCT)
Time Frame: Up to 3 years 1 month
Percentage of participants with acute leukaemia and MDS who receive subsequent allogeneic HSCT will be reported.
Up to 3 years 1 month
Module 1 and Module 2: Overall Response Rate (ORR)
Time Frame: Up to 3 years 1 month
ORR in participants with myelodysplastic syndromes (MDS) is defined as the percentage of participants who have a CR (or CR equivalent), CRL, CRh, PR, or HI as determined by investigator at a local site.
Up to 3 years 1 month
Module 1 and Module 2: Time to Progression to acute myeloid leukaemia (AML)
Time Frame: Up to 3 years 1 month
Time to progression to AML is defined from the time of first dose of AZD3632 until first diagnosis of AML, regardless of discontinuation of treatment or receiving of subsequent therapy.
Up to 3 years 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8620C00001
  • 2025-521299-76-00 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portalVivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitment a made to the EFPIA PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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