AZD9829 for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD9829 for certain types of blood cancers. The goal is to determine the right dose and assess its safety and effectiveness, either alone or with other treatments. It targets individuals with blood cancers that test positive for CD123, such as acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (HR-MDS), who have not responded to other treatments. Participants should not have active central nervous system leukemia and should not have received similar treatments targeting CD123 before. This trial may suit those with no remaining treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that AZD9829 is likely to be safe for humans?
Research has shown that AZD9829 has been tested in lab studies on monkeys. These studies suggest potential for development in treating certain blood cancers, such as acute myeloid leukemia (AML). In these tests, AZD9829 produced promising results with only mild effects on healthy cells, indicating it might be well-tolerated in humans.
Although limited safety data from human trials exists, the treatment remains in early testing stages. Researchers are focused on understanding its safety and determining the right dose. Because AZD9829 is in these early stages, it is still under close study for any side effects in people.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AZD9829 because it targets CD123, a molecule commonly found on the surface of certain blood cancer cells like those in relapsed or refractory acute myeloid leukemia (R/R AML). Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, AZD9829 is designed to specifically recognize and bind to CD123, potentially reducing damage to healthy cells and minimizing side effects. This targeted approach might offer a more effective and safer alternative to the current standard treatments, which often include chemotherapy and stem cell transplants. Additionally, AZD9829 may provide hope for patients with R/R AML who have few other options.
What evidence suggests that AZD9829 might be an effective treatment for blood cancers?
Research has shown that AZD9829 holds promise for treating blood cancers with the CD123 marker. In one study, AZD9829 reduced cancerous white blood cells by at least 50% in both blood and bone marrow samples from six out of seven models tested. This result indicates a significant reduction in cancer cells. Importantly, the drug specifically targets cancer cells, with minimal impact on healthy cells. The trial will explore AZD9829 in two separate treatment arms: one focusing on dose escalation and the other on dose optimization. These findings suggest that AZD9829 could effectively treat certain blood cancers, such as acute myeloid leukemia (AML).56789
Are You a Good Fit for This Trial?
This trial is for individuals with blood cancers that express a marker called CD123. Specific details about who can join or reasons why someone might not be eligible are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Ascending dose level cohorts of AZD9829 in AML and MDS participants to determine safety and tolerability
Dose Optimization
Characterizing the safety, tolerability, PK/PD, and preliminary antitumor activity of AZD9829 in CD123+ R/R AML participants
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD9829
Trial Overview
The study is testing AZD9829, given through the vein either alone or with other treatments, to see how it works in treating various blood cancers marked by CD123.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Characterizing the safety, tolerability, PK/PD, and preliminary antitumor activity of AZD9829 in CD123+ R/R AML participants, based on the data collected during dose escalation, dose optimization and backfill.
Ascending dose level cohorts of AZD9829 in AML and MDS participants.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
1.
library.ehaweb.org
library.ehaweb.org/eha/2024/eha2024-congress/document?c_id=420584&cm_id=435417&type=document435417azd9829 demonstrates combination benefit with hma and ...
Our preclinical findings also offer justification for exploring combinations of AZD9829 with SoC drugs in the clinic to improve long-term AML patient outcomes.
First Disclosure of AZD9829, a TOP1i-ADC Targeting CD123
AZD9829 achieved ≥50% leukemic blast reduction in blood (7/7 models) (Figure 2) and in bone marrow (6/7 models) at day 14 after the first dose.
A bispecific antibody–drug conjugate targeting CD7 and ...
Aberrant expression of CD7 in AML patients is linked to shorter overall survival and lack of response to standard of care therapy. CD33/CD7 co- ...
4.
astrazeneca.com
astrazeneca.com/content/dam/az/PDF/2023/fy/Full-year-and-Q4-2023-results-clinical-trials-appendix.pdfFull-year-and-Q4-2023-results-clinical-trials-appendix.pdf
AZD9829 (CD123 TOP1i ADC) acute myeloid leukaemia, myelodysplastic syndromes. COVID mRNA VLP vaccine# (vaccine). COVID-19. Additional ...
5.
pharmaceutical-technology.com
pharmaceutical-technology.com/data-insights/azd-9829-astrazeneca-relapsed-acute-myeloid-leukemia-likelihood-of-approval/AZD-9829 by AstraZeneca for Relapsed Acute Myeloid ...
According to GlobalData, Phase II drugs for Relapsed Acute Myeloid Leukemia have a 20% phase transition success rate (PTSR) indication benchmark ...
First Disclosure of AZD9829, a TOP1i-ADC Targeting ...
Safety studies in cynomolgus monkey support the clinical development of AZD9829, a promising therapeutic candidate for the treatment of AML ...
Study of AZD9829 in CD123+ Hematological Malignancies
This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in ...
Study of AZD9829 in CD123+ Hematological Malignancies
Characterizing the safety, tolerability, PK/PD, and preliminary antitumor activity of AZD9829 in CD123+ R/R AML participants, based on the data collected during ...
Medicines: Oncology Portfolio and Pipeline
AZD9829 acute myeloid leukemia, myelodysplastic syndromes. AZD9829 - Phase I ... data or safety data. Please refer to your approved national product ...
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