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Tests treatment safety and results for ER+ HER2- Advanced Breast Cancer
Official title A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06188520
What this study is testing
What is AZD8421?
AZD8421 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for er+ her2- advanced breast cancer.
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
- This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female participants only, aged 18 or above
- Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of...
- Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to...
- ECOG/WHO performance status 0 to 1, and a minimum life expectancy of 12 weeks.
- At least one lesion that is measurable and/or non-measurable, as per RECIST v1.1 and that can be accurately assessed at baseline and is suitable for...
You likely can't join if
- Intervention with any of the following:
- Any cytotoxic chemotherapy, investigational agents, or other anti-cancer drugs for the treatment of advanced cancer from a previous treatment regimen...
- Any prescription or non-prescription drugs or other products, including herbal products, known to be moderate or strong inhibitors/inducers of...
- Drugs that have a known risk of Torsades de Pointes.
- Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of IMP.
- Major surgical procedure or significant traumatic injury, within 4 weeks of the first dose of IMP, or an anticipated need for major surgery and/or...
See the full eligibility criteria
- Female participants only, aged 18 or above
- Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical study is...
- Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting IMP.
- ECOG/WHO performance status 0 to 1, and a minimum life expectancy of 12 weeks.
- At least one lesion that is measurable and/or non-measurable, as per RECIST v1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment.
- Intervention with any of the following:
- Any cytotoxic chemotherapy, investigational agents, or other anti-cancer drugs for the treatment of advanced cancer from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is...
- Any prescription or non-prescription drugs or other products, including herbal products, known to be moderate or strong inhibitors/inducers of CYP3A4/5 which cannot be discontinued prior to first dose of IMP and...
- Drugs that have a known risk of Torsades de Pointes.
- Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of IMP.
- Major surgical procedure or significant traumatic injury, within 4 weeks of the first dose of IMP, or an anticipated need for major surgery and/or any surgery requiring general anesthesia during the study.
- Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia). Participants with stable ≤ Grade 2 neuropathy are eligible.
- Presence of life-threatening metastatic visceral disease, as judged by the Investigator, uncontrolled CNS metastatic disease. Participants with spinal cord compression and/or brain metastases may be enrolled if...
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or eg, infection requiring IV antibiotic therapy, or active infection including hepatitis B...
- Any of the following cardiac criteria:
- Mean resting QTcF \> 470 msec obtained from a triplicate ECG
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (eg, complete left bundle branch block, second- and third-degree heart block), or clinically significant sinus pause...
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as symptomatic heart failure, hypokalemia, congenital long QT syndrome, immediate family history of long QT syndrome or...
- LVEF \< 50%, and/or experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris...
- Uncontrolled hypertension.
- Inadequate bone marrow reserve or organ function as demonstrated by relevant laboratory values:
- Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, or previous significant bowel resection that would preclude adequate absorption of IMP(s).
- History of hypersensitivity to active or inactive excipients of AZD8421 or drugs with a similar chemical structure or class to AZD8421.
- Previous treatment with AZD8421 or with any CDK2-selective inhibitor, or protein kinase membrane-associated tyrosine- and threonine-specific cdc2-inhibitory kinase 1 (PKMYT1) inhibitor, or WEE1 inhibitor.
- Currently pregnant (confirmed with positive pregnancy test), breast feeding, or planning to become pregnant. Participants of childbearing potential must agree to use one highly effective contraceptive measure.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
- Providence, Rhode Island, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- East Melbourne, Australia
- Seoul, South Korea
- Barcelona, Spain
- Pamplona, Spain
- Valencia, Spain
- Cambridge, United Kingdom
- Leeds, United Kingdom
- 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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States; Providence, Rhode Island, United States; Nashville, Tennessee, United States; Houston, Texas, United States; East Melbourne, Australia; Seoul, South Korea and 7 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.