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RecruitingPHASE2INTERVENTIONAL

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

This important study, called TROPION-PanTumor03, is investigating a new medication called Datopotamab Deruxtecan (Dato-DXd). Researchers want to see how safe and effective Dato-DXd is, both on its own and when combined with other cancer drugs. It's for people with advanced cancers that have spread, including types affecting the womb, stomach, prostate, ovaries, bowel, bladder, and bile ducts. The study aims to find the best way to use Dato-DXd and gather more information about its effects on various advanced solid tumours. It's a Phase 2 study, meaning it's still in the earlier stages of testing new treatments, but it's crucial for understanding how these treatments might help patients in the future.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
454
Start
06 Sep 2022
Estimated completion
01 Oct 2027

What is this study about?

This study, known as TROPION-PanTumor03, is looking into a new medication called Datopotamab Deruxtecan, or Dato-DXd for short. The main goal is to understand how safe this drug is and if it can help people with different types of advanced cancers. When we say 'advanced cancer,' we mean cancer that has spread to other parts of the body.

The researchers will test Dato-DXd in two ways: some people will receive Dato-DXd by itself, while others will get Dato-DXd along with other existing cancer treatments. This allows the study to explore different treatment approaches. They are studying it for a range of cancers, including those of the womb (endometrial cancer), stomach, prostate (when it's resistant to standard hormone treatments), ovaries, bowel (colorectal cancer), bladder, and bile ducts.

This is a 'Phase 2' study, which means it’s an important step in developing new medicines. It focuses on finding the right dose and gathering more information about the drug's effects. The study is designed to be flexible, allowing researchers to study different cancers and drug combinations at the same time to speed up learning and potentially help patients sooner.

Key takeaways

  • This study investigates a new cancer drug called Dato-DXd for advanced solid tumours.
  • It tests Dato-DXd alone and in combination with other anti-cancer medicines.
  • It includes cancers like womb, stomach, prostate, ovarian, bowel, bladder, and bile duct cancer.
  • It's a Phase 2 study, focusing on safety and effectiveness.
  • Participation involves regular hospital visits for treatment and check-ups.

Who may be eligible?

To join this study, you must be 18 years or older and have a confirmed diagnosis of advanced or metastatic cancer. This means your cancer has spread beyond its original site.

You should also be generally well enough to take part in the study, meaning you can do most of your daily activities. You'll need to provide a small sample of your cancer tissue for analysis and have at least one measurable tumour that hasn't been treated with radiation recently (though there are special rules for prostate cancer). Your blood counts and organ functions also need to be within a healthy range.

There are also important rules about contraception for both men and women to prevent pregnancy during the study. You simply need to be able to understand and sign the consent forms. People who have other serious health conditions that could make taking part unsafe, or who have recently had another type of cancer (unless it was completely removed), may not be able to join.

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 18 years of age or older?
  2. Do you have a diagnosis of advanced or metastatic cancer?
  3. Are you generally well enough to go about your daily life?
  4. Do you understand that you'll need to provide a cancer tissue sample?
  5. Are you willing and able to comply with the study's contraception rules if applicable?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if the study is right for you. This will involve physical examinations, blood tests, and scans. You'll regularly visit the hospital or clinic for your study medication, which might be Dato-DXd on its own or with other anti-cancer drugs. These visits will also include repeat tests like blood tests and scans to see how you're responding to the treatment and to check for any side effects.

The exact number of visits, tests, and the length of your participation will depend on the specific cancer type you have and how your body responds to the treatment. The study team will explain your specific schedule in detail. There will also be follow-up appointments after your treatment period to monitor your health.

Potential risks and benefits

Taking part in any clinical trial comes with potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could help your cancer. However, there's no guarantee that the treatment will work for you, and it might not be more effective than standard treatments. You might experience side effects from the study medication, which the medical team will monitor closely. We don't know all the side effects yet, which is part of what the study aims to understand. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (95)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Research Site
    Verified postcode
    San Diego, United States· Withdrawn
  • Research Site
    Verified postcode
    Santa Rosa, United States· Recruiting
  • Research Site
    Verified postcode
    Muncie, United States· Withdrawn
  • Research Site
    Verified postcode
    Kansas City, United States· Withdrawn
  • Research Site
    Verified postcode
    Boston, United States· Withdrawn
  • Research Site
    Verified postcode
    Boston, United States· Completed
  • Research Site
    Verified postcode
    Grand Rapids, United States· Recruiting
  • Research Site
    Verified postcode
    East Brunswick, United States· Recruiting
  • Research Site
    Verified postcode
    Albuquerque, United States· Recruiting
  • Research Site
    Verified postcode
    Commack, United States· Recruiting
  • Research Site
    Verified postcode
    Cincinnati, United States· Recruiting

Common questions

What is advanced solid tumour cancer?

This means cancer that has grown and spread from its original location to other parts of your body, forming solid lumps.

What is Dato-DXd?

Dato-DXd is a new drug being tested to see if it can help treat various types of advanced cancer.

What does 'monotherapy' mean?

Monotherapy means you receive only one drug (Dato-DXd) as your treatment, without other cancer medicines.

Will I definitely receive Dato-DXd?

Yes, everyone in this study will receive Dato-DXd, either on its own or combined with other anti-cancer medicines.

How long will the study last for me?

The length of time you participate will depend on your specific situation and how you respond to the treatment. The study team will explain this to you.

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 "Study of Dato-DXd as Monotherapy and in Combination With Ant…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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