AZD8421 for Advanced Breast or Ovarian Cancer
This study is testing a new drug called AZD8421, alone or with other cancer medicines, in women with advanced breast cancer (ER+ HER2- type) or high-grade serous ovarian cancer. AZD8421 works by targeting CDK2, a protein involved in cancer growth. The study will look at how safe and tolerable AZD8421 is, and if it shows any early signs of helping to treat these cancers. You may be able to join if you are an adult woman with one of these cancers and have already received standard treatments, or if your doctor believes this study is your best treatment option. The main goals are to track side effects and changes in your health.
- Study design
- This is a first-in-human study, meaning it's the first time AZD8421 is being given to people. It plans to enroll 564 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the start of treatment until approximately 18 months after treatment ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06188520
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
Recruiting
PHASE1Ages 18+InterventionalTreatmentAstraZeneca
~564 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:AZD8421CamizestrantRibociclibPalbociclibAbemaciclib
At a glance
Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLTs) as defined in the protocol.
Measured over From start of treatment until the end of DLT period, assessed up to 28 days.
+3 more outcomes measured
Conditions
Where it's being run
14 sites across 8 statesUnited Kingdom4
Spain3
South Korea2
Missouri1
Rhode Island1
Tennessee1
Texas1
Australia1
Study leadership
- Richard Baird, MD, PhD · STUDY_CHAIR · Cambridge University Hospitals
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 the best option for their next treatment based on response to and/or tolerability of prior therapy.
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.
Exclusion
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 shorter) of the first dose of IMP (21 days for myelosuppressive therapies) other than GnRHa (eg, goserelin) and bone-stabilizing agents (eg, zoledronic acid, denosumab).
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 withheld throughout the study until 2 weeks after the last dose of study drug.
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 definitively treated (eg, surgery or radiotherapy) and stable off steroids for at least 4 weeks prior to start of IMP.
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, hepatitis C, and HIV (active viral infection is defined as requiring antiviral therapy; screening for chronic conditions is not required).
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. Participants with controlled atrial fibrillation can be enrolled.
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 unexplained sudden death at \< 40 years of age. Hypertrophic cardiomyopathy and clinically significant stenotic valve disease.
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, congestive heart failure NYHA Grade ≥ 2, cerebrovascular accident, or transient ischemic attack.
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.
What this trial measures
- Incidence of dose limiting toxicities (DLTs) as defined in the protocol.From start of treatment until the end of DLT period, assessed up to 28 days.
Percentage of participants with incidence of DLTs.
- Incidence of AEs/SAEsFrom start of treatment until the end of safety follow-up, approximately 18 months.
Percentage of participants with incidence of AEs/SAEs.
- Clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.From start of treatment until the end of safety follow-up, approximately 18 months.
Percentage of participants with clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.
- Discontinuation of AZD8421 due to toxicityFrom start of treatment until the end of safety follow-up, approximately 18 months.
Percentage of participants that have discontinued AZD8421 due to toxicity.