Treatment with AZD9829 for blood cancers
A Modular Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients With CD123-Positive Hematological Malignancies
This study is testing a new cancer drug called AZD9829 to see if it helps people with certain blood cancers who have already tried other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 24 sites (Duarte, California and 23 other locations) |
| Trial ID | NCT06179511 on ClinicalTrials.gov |
What this trial studies
This is a modular, multicenter, open-label study evaluating the safety and efficacy of AZD9829, an anti-cancer agent, in patients with CD123 positive hematological malignancies. The study will involve dose escalation and may include AZD9829 as a monotherapy or in combination with other treatments. Participants must have previously received at least one line of therapy and have no available treatment options left. The study aims to determine the optimal dosing and assess the drug's effectiveness in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with CD123 positive hematological malignancies who have exhausted other treatment options.
Not a fit: Patients with active CNS leukemia or those who have previously received CD123 targeting therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.
How similar studies have performed: While this approach is novel in its specific application, similar studies targeting hematological malignancies have shown promising results with other therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years of age; * CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory; * R/R AML (except APL); * R/R HR-MDS with ≥5% bone marrow blast at time of inclusion; * Had at least 1 prior line of therapy at currents histology, and have no available treatment options; * ECOG performance status of ≤ 2. The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active CNS leukemia; * Previous treatment with any CD123 targeting therapy; * Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy; * Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829; * History of other malignancy(with certain exceptions); * Active and uncontrolled infections; * Unresolved AEs ≥2 Grade, from prior therapies. The above is a summary, other exclusion criteria details may apply.
Where this trial is running
Duarte, California and 23 other locations
- Research Site — Duarte, California, United States (Recruiting)
- Research Site — Saint Louis, Missouri, United States (Recruiting)
- Research Site — New York, New York, United States (Recruiting)
- Research Site — Chapel Hill, North Carolina, United States (Recruiting)
- Research Site — Columbus, Ohio, United States (Recruiting)
- Research Site — Houston, Texas, United States (Recruiting)
- Research Site — Milwaukee, Wisconsin, United States (Recruiting)
- Research Site — Heidelberg, Australia (Recruiting)
- Research Site — Melbourne, Australia (Recruiting)
- Research Site — Guangzhou, China (Recruiting)
- Research Site — Tianjin, China (Recruiting)
- Research Site — Zhengzhou, China (Not_yet_recruiting)
- Research Site — Frankfurt, Germany (Recruiting)
- Research Site — Bologna, Italy (Recruiting)
- Research Site — Kashiwa, Japan (Recruiting)
- Research Site — Osaka-shi, Japan (Recruiting)
- Research Site — Yoshida-gun, Japan (Recruiting)
- Research Site — Seoul, Korea, Republic of (Recruiting)
- Research Site — Seoul, Korea, Republic of (Recruiting)
- Research Site — Barcelona, Spain (Recruiting)
- Research Site — Salamanca, Spain (Recruiting)
- Research Site — Tainan, Taiwan (Recruiting)
- Research Site — Taipei, Taiwan (Recruiting)
- Research Site — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.