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RecruitingPHASE1, PHASE2INTERVENTIONAL

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

This research study is testing a new medicine called AZD8421. It's for women with certain types of advanced breast cancer (ER+ HER2- breast cancer) and a specific type of advanced ovarian cancer. The doctors want to find out if AZD8421 is safe and if it can help stop the cancer from growing. They will be looking at AZD8421 on its own, and also seeing how it works when given alongside other established cancer treatments. This is one of the first times this drug is being used in people, so it's an important early step in understanding its potential benefits. The study will help determine the right dose to use in future research.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
AstraZeneca
Enrolment target
564
Start
05 Dec 2023
Estimated completion
04 Aug 2027

What is this study about?

This study is about a new investigational drug called AZD8421. An "investigational drug" means it's still being researched and isn't yet available as a standard treatment. The main goals are to see how safe AZD8421 is, if people can tolerate it, and if it shows any signs of working against certain types of cancer. This particular study focuses on two specific cancers: advanced breast cancer that is Estrogen Receptor positive and HER2 negative (often called ER+ HER2-), and a type of advanced ovarian cancer called high-grade serous ovarian cancer.

The study will look at AZD8421 in two ways. Firstly, some participants will receive AZD8421 on its own. Secondly, other participants will receive AZD8421 along with other anti-cancer medications that are already approved, such as Camizestrant, Ribociclib, Palbociclib, or Abemaciclib. This helps researchers understand if combining treatments might be more effective or if there are any new side effects when used together. This early stage of research is crucial for understanding how the drug works in the human body.

Because this is one of the first times AZD8421 is being given to people, the study design is careful. It starts with lower doses and gradually increases them, closely watching for any side effects. This process helps the researchers find the best and safest dose to use in future, larger studies. The information gathered here will be vital in deciding if AZD8421 has the potential to become a new treatment option for people with these cancers.

Key takeaways

  • Tests a new drug (AZD8421) for advanced breast and ovarian cancers.
  • Investigates AZD8421 alone and in combination with other treatments.
  • Aims to find a safe and effective dose.
  • Open to women aged 18+ with specific cancer types.
  • Participation involves regular clinic visits and monitoring.

Who may be eligible?

This study is open to women aged 18 or older who have advanced solid tumours. Specifically, if you have advanced breast cancer (ER+ HER2- type) that has progressed after a previous treatment called a CDK4/6 inhibitor, or if you have advanced high-grade serous ovarian cancer that has progressed after platinum-based chemotherapy, you might be suitable.

To join, your doctor must agree that participating in this study is a good option for your next treatment. You\'ll need to be generally well enough to take part, meaning you can carry out most daily activities without too much difficulty, and have a reasonable life expectancy. Doctors will also need to be able to measure your cancer to see how the treatment is working.

There are certain reasons why you might not be able to join. For example, if you've recently had other cancer treatments, major surgery, or radiotherapy, you might need to wait a bit. Also, if you're taking certain medications that might interfere with AZD8421, or if you have unresolved side effects from previous treatments that are still severe, you might not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you female and 18 years or older?
  2. Do you have ER+ HER2- advanced breast cancer or high-grade serous ovarian cancer?
  3. Has your cancer progressed after previous standard treatments?
  4. Are you generally well enough for daily activities (ECOG/WHO performance status 0-1)?
  5. Have you discussed this study with your doctor as a potential next step for your treatment?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive AZD8421, either on its own or in combination with other anti-cancer drugs. You will have regular visits to the clinic so the medical team can monitor your health, check for any side effects, and see how you are responding to the treatment. These visits will involve blood tests, physical examinations, and scans to track the cancer. The total duration of your participation will depend on how you respond to the treatment and the phase of the study you are in, but the medical team will explain this in detail. After finishing the study drug, there will be follow-up visits to continue monitoring your health.

Potential risks and benefits

Participating in this study might offer a potential benefit of accessing a new treatment (AZD8421) that isn't yet widely available, which could potentially help control your cancer. However, as with any new drug, there are potential risks and side effects that are not fully known yet. The study team will closely monitor you for any adverse effects and will explain all known risks. Remember, taking part in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    St Louis, United States· Recruiting
  • Research Site
    Verified postcode
    Providence, United States· Recruiting
  • Research Site
    Verified postcode
    Nashville, United States· Recruiting
  • Research Site
    Verified postcode
    Houston, United States· Recruiting
  • Research Site
    Verified postcode
    East Melbourne, Australia· Recruiting
  • Research Site
    Verified postcode
    Seoul, South Korea· Recruiting
  • Research Site
    Verified postcode
    Seoul, South Korea· Recruiting
  • Research Site
    Verified postcode
    Barcelona, Spain· Recruiting
  • Research Site
    Verified postcode
    Pamplona, Spain· Recruiting
  • Research Site
    Verified postcode
    Valencia, Spain· Recruiting
  • Research Site
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • Research Site
    Verified postcode
    Leeds, United Kingdom· Recruiting

Common questions

What is AZD8421?

AZD8421 is a new medicine being tested in this study to see if it can treat certain types of advanced breast and ovarian cancer.

Who can join this study?

This study is for women aged 18 or over with specific types of advanced breast or ovarian cancer who meet other health requirements.

Will I take AZD8421 alone or with other drugs?

Some participants will receive AZD8421 by itself, while others will take it alongside other established cancer medications.

What does 'first-in-human' mean?

It means this is one of the first times this drug is being given to people, so researchers are carefully checking its safety and effects.

Can I stop participating anytime?

Yes, you have the right to leave the study at any point, and your decision won't affect your future medical care.

How to find out more

AstraZeneca Clinical Study Information Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A First-in-human Dose Escalation and Expansion Study to Eval…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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