AZD3632 for Acute Myeloid Leukemia

(MOMENTUM Trial)

Not yet recruiting at 25 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests AZD3632, a new oral treatment, to determine its safety and effectiveness for individuals with advanced blood cancers such as acute myeloid leukemia. It explores different doses of AZD3632 alone and in combination with another drug, posaconazole. Individuals with relapsed or hard-to-treat leukemia or myelodysplastic syndrome (a blood disorder) who have specific genetic changes might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain anticancer agents or radiation therapy recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that AZD3632 is being tested for safety and tolerability in people with advanced blood cancers. These studies examine how the body processes the drug and its effects. Although detailed safety information is not yet available, the drug remains in the early stages of testing, requiring further research to understand its tolerance.

Similarly, studies are testing the combination of AZD3632 and posaconazole for safety and tolerability. These trials aim to determine the safety of this combination for participants. Like AZD3632 alone, these studies are in the early stages, so researchers are still learning about possible side effects.

With both treatments in early trials, information on side effects is limited. Participants in these studies help scientists learn about the risks and benefits of the treatments, a crucial step in developing new therapies.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD3632 for treating acute myeloid leukemia (AML) because it represents a novel approach to tackling this aggressive cancer. Unlike traditional chemotherapy drugs, which often target rapidly dividing cells broadly, AZD3632 is designed to specifically interfere with the cancer cell's ability to survive and proliferate without harming normal cells as much. Additionally, some trial arms explore combining AZD3632 with posaconazole, which might enhance its effectiveness by adding an antifungal agent that could further protect patients with weakened immune systems. This combination approach adds a layer of innovation and potential increased safety and efficacy compared to existing treatment options.

What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?

Research shows that AZD3632 is being developed to target specific genetic changes found in some blood cancers, such as acute myeloid leukemia (AML). It disrupts the processes that help cancer cells grow. In this trial, participants will receive varying doses of AZD3632 to evaluate its effectiveness. Additionally, some participants will receive AZD3632 combined with posaconazole, which reduces the risk of infections—an important consideration for AML patients. Although data on AZD3632's effectiveness is still being gathered, its targeted approach offers hope for better outcomes in treating advanced blood cancers.14678

Are You a Good Fit for This Trial?

This trial is for adults with advanced blood cancers like Myelodysplastic Syndromes or various types of Leukemia. Participants must have specific genetic markers (KMT2Ar, NPM1m, or others linked to HOX overexpression). The full eligibility criteria are not provided here.

Inclusion Criteria

Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
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 relapsed/refractory (R/R) and measurable disease: a) Relapsed and refractory (R/R) acute leukaemia after standard of care therapy including but not limited to 1 to 2 cycles of intensive chemotherapy or venetoclax combinations; b) R/R MDS is defined by ≥ 5% blasts in the bone marrow and/or persistence of peripheral blasts after treatment with at least an 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
See 2 more

Exclusion Criteria

Abnormal levels of potassium or magnesium prior to first dose of AZD3632
I have not received any standard cancer treatments or radiation.
I have been diagnosed with Burkitt lymphoma/leukaemia or Acute Promyelocytic Leukaemia.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AZD3632 monotherapy or in combination with posaconazole, with dose escalation in Module 1 and combination treatment in Module 2

Up to 3 years 10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events and pharmacokinetics

Up to 3 years 10 months

What Are the Treatments Tested in This Trial?

Interventions

  • AZD3632
Trial Overview The study tests AZD3632 alone and combined with other cancer drugs in patients. It aims to assess safety, how well the body handles the drug (PK), how it affects the body (PD), and its initial effectiveness against certain blood cancers.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Module 2: AZD3632 + posaconazoleExperimental Treatment2 Interventions
Group II: Module 1: AZD3632 dose 6Experimental Treatment1 Intervention
Group III: Module 1: AZD3632 dose 5Experimental Treatment1 Intervention
Group IV: Module 1: AZD3632 dose 4Experimental Treatment1 Intervention
Group V: Module 1: AZD3632 dose 3Experimental Treatment1 Intervention
Group VI: Module 1: AZD3632 dose 2Experimental Treatment1 Intervention
Group VII: Module 1: AZD3632 dose 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Citations

AZD3632 for Acute Myeloid Leukemia · Info for ParticipantsIt aims to assess safety, how well the body handles the drug (PK), how it affects the body (PD), and its initial effectiveness against certain blood cancers.
AZD3632 for Advanced Hematologic Malignancies with ...The aim is to assess the safety and effectiveness of this drug, either on its own or combined with other cancer treatments. This research is ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40453057/
Real-world outcomes of newly diagnosed AML treated with ...Patients receiving venetoclax-azacitidine had a complete remission (CR)/CR with incomplete hematological recovery rate of 67%, day 30 and day 60 ...
AstraZeneca's New Study on AZD3632: A Potential Game ...' The study aims to assess the safety and efficacy of AZD3632, a drug designed to treat advanced blood cancers characterized by specific genetic ...
Sprycel: Everything you need to know | PowerAZD3632 for Acute Myeloid Leukemia ... This trial aims to investigate the safety, effectiveness, and how the body processes a drug called AZD3632 when given by ...
Study of AZD3632 Monotherapy or in Combination With ...The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary ...
Study of AZD3632 Monotherapy or in Combination With ...Safety and tolerability of AZD3632 monotherapy in participants with advanced haematologic malignancies will be assessed. Up to 3 year 10 months. Module 1 and ...
MA+AZA Regimen for the Treatment of Newly Diagnosed ...Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML).
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