BridgeMD
New treatment option for Haematologic Neoplasms
Official title A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)
ClinicalTrials.gov ID: NCT07064122
What this study is testing
What is AZD2962?
AZD2962 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for haematologic neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of the study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD2962, an Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor, as monotherapy and in combination with other agents in participants with haematologic neoplasms.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 110
You may be able to join if
- Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts \<...
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Participants must have symptomatic disease that requires therapy and allows for objective how well it works assessments.
- Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
- Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol...
You likely can't join if
- Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
- Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
- Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
- Received major surgery within 28 days prior to first dose, or still recovering from surgery.
- Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes, within 15 days prior to first dose.
- Received immunosuppressive medications (including Graft-Versus-Host Disease prophylaxis) within 28 days prior to first dose, or within 15 days in the...
See the full eligibility criteria
- Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts \< 20%, and who received one or more prior lines of therapy as per...
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- Participants must have symptomatic disease that requires therapy and allows for objective how well it works assessments.
- Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
- Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol requirements.
- All women of childbearing potential must have a negative serum pregnancy test result at Screening. Key
- Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
- Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
- Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
- Received major surgery within 28 days prior to first dose, or still recovering from surgery.
- Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes, within 15 days prior to first dose.
- Received immunosuppressive medications (including Graft-Versus-Host Disease prophylaxis) within 28 days prior to first dose, or within 15 days in the case of systemic steroids (doses exceeding 10 mg/day of prednisone or...
- Received live attenuated vaccines within 28 days prior to first dose.
- Active major bleeding event.
- Any evidence of systemic disease, significant clinical disorder, or laboratory finding that make undesirable the participation in the study. 15\. Mean resting corrected QT interval using Fridericia's formula (QTcF) \>...
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Tampa, Florida, United States
- Houston, Texas, United States
- Heidelberg, Australia
- Melbourne, Australia
- Shinagawa-ku, Japan
- Yoshida-gun, Japan
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
- Pamplona, Spain
- Salamanca, Spain
- Valencia, Spain
- Kaohsiung City, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- London, United Kingdom
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 110 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Tampa, Florida, United States; Houston, Texas, United States; Heidelberg, Australia; Melbourne, Australia; Shinagawa-ku, Japan and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.