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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (4 UK sites)
Research Site
Cambridge CB2 0XY, United Kingdom
Research Site
Leeds LS9 7TF, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
