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Looking for participantsPhase1/Phase2

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

Sponsor: AstraZeneca

NCT ID: NCT06188520

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD8421 (drug), Camizestrant (drug), Ribociclib (drug), Palbociclib (drug)
How long the study runs
Study runs about 44 months (dates as stated)
About the drug or intervention
AZD8421 — drug: CDK2 inhibitor · Camizestrant — drug: SERD · Ribociclib — drug: CDK4/6 inhibitor · Palbociclib — drug: CDK4/6 inhibitor · Abemaciclib — drug: CDK4/6 inhibitor
Patient visit burden
Not specified by the sponsor

In plain English

This is a first-in-human study testing a new drug called AZD8421, given alone or with other medicines, in women with certain advanced or metastatic (spread) solid tumours. These are ER+ HER2- advanced breast cancer and high-grade serous ovarian cancer (HGSOC). The study will look at how safe the drug is and how well people can tolerate it.

Who can take part

  • Women aged 18 or over.
  • Have an advanced solid tumour and have already had standard treatment suitable for their cancer type and stage, or a study is thought to be the best next option.
  • Have cancer that has spread or come back locally, with evidence it got worse on or after the last treatment.
  • Be well enough for everyday activity (performance status 0 to 1) with a life expectancy of at least 12 weeks.
  • Have at least one tumour that can be measured or assessed with scans at the start and repeatedly during the study.

Who may not be able to

  • Had chemotherapy, other anti-cancer drugs, or experimental treatments recently (within 14 days or 5 half-lives, or 21 days for some therapies).
  • Cannot stop taking certain medicines, including herbal products, that affect how the body processes AZD8421, or drugs with a known risk of a serious heart rhythm problem called Torsades de Pointes.
  • Had palliative radiotherapy within 1 week, major surgery or serious injury within 4 weeks, or expecting major surgery during the study.
  • Still have significant side effects (Grade 2 or more) from previous cancer treatment, except hair loss; stable mild-to-moderate nerve damage is allowed.
  • Have uncontrolled cancer spread to the brain or spinal cord, or life-threatening cancer in organs (treated and stable brain metastases may be allowed).
  • Have severe or uncontrolled illnesses, such as uncontrolled high blood pressure, bleeding problems, serious infections, hepatitis B, hepatitis C or HIV needing treatment.
  • Have certain heart problems, including a long QT interval on heart traces, serious rhythm problems, heart failure, recent heart attack or stroke, or a heart pumping function below 50%.
  • Have poor bone marrow, blood counts, liver or kidney function on lab tests.
  • Have ongoing nausea, vomiting, gut disease, or major bowel surgery that could stop the drug being absorbed.
  • Are allergic to AZD8421 or similar drugs.
  • Have previously taken AZD8421 or any drug of the same types (CDK2, PKMYT1 or WEE1 inhibitors).
  • Are pregnant, breastfeeding, planning pregnancy, or unable/unwilling to use highly effective contraception if able to become pregnant.

What taking part involves

  • • Taking the experimental drug AZD8421, either on its own or combined with other medicines (details of combinations: not stated — ask the trial team).
  • • Repeated scans and checks to measure the tumour and monitor safety.

Time commitment: Not stated — ask the trial team (the data does not give visit frequency, study duration, or dose schedule).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Female
Number of participants
564
Started
2023-12-05
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for er+ her2- advanced breast cancer
  • • Phase1/Phase2 - 564 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with er+ her2- advanced breast cancer
  • • Female only

Where?

  • • Cambridge - Research Site
  • • Leeds - Research Site
  • • London - Research Site
  • • Manchester - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This is a first in-human study of AZD8421 administered to participants with advanced or metastatic solid tumors. The study will evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of AZD8421 alone and in combination with selected targeted anti-cancer drugs. AZD8421 monotherapy (M1) will evaluate the safety, tolerability and pharmacokinetics of AZD8421 as monotherapy to identify a recommended Phase II dose (RP2D) in participants with ER+ HER2- advanced breast cancer previously treated with a CDK4/6i (Parts A and B) and participants with metastatic high-grade serous ovarian cancer previously treated with a platinum-based chemotherapy in the metastatic setting (Part B). AZD8421 combination therapy (M2) will evaluate the safety, tolerability, and pharmacokinetics of different formulations of AZD8421 in combination with a CDK4/6 inhibitor (one or more of abemaciclib, ribociclib and palbociclib) and camizestrant (next generation oral SERD; referred to throughout as 'camizestrant') in participants with ER+ HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor.

ER+ HER2- Advanced Breast CancerHigh-grade Serous Ovarian Cancer (HGSOC)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Female only

Biomarkers mentioned

with positive

What the study is looking for

  • ✓Female participants only, aged 18 or above
  • ✓that has spread or locoregionally recurrent disease and radiological or objective evidence of progression on or after the...
  • ✓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 (standard scan measurements) and that can be accurately assessed...

Who cannot take part

  • ✗Intervention with any of the following:
  • ✗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.
  • ✗Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia). Participants...
  • ✗Any of the following heart criteria:
See the full criteria
Inclusion 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 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 Criteria: * 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.

Where Is This Study? (4 UK sites)

Research Site

Cambridge CB2 0XY, United Kingdom

Recruiting

Research Site

Leeds LS9 7TF, United Kingdom

Recruiting

Research Site

London EC1A 7BE, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08