Active not recruitingPHASE2INTERVENTIONAL

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

This research study, called a Phase 2 trial, is testing an investigational drug, trastuzumab deruxtecan (T-DXd), in people with various advanced cancers. These include cancers of the bladder, bile duct, cervix, womb, ovary, and pancreas, as well as some rarer types. The study focuses on cancers that have a specific protein called HER2. Researchers are looking to understand how effective T-DXd is at treating these cancers and to carefully monitor any side effects. This study is ‘open-label’, meaning both patients and doctors will know which treatment is being given. It aims to see if T-DXd could offer a new treatment option for people whose cancer has progressed or for whom other treatments haven't worked.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

477

Start

18 Aug 2020

Estimated completion

23 Mar 2027

Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer

What is this study about?

This study is a Phase 2 clinical trial, which means it's one of the earlier stages of testing a new medicine in people. The main goal is to find out if a drug called trastuzumab deruxtecan (often shortened to T-DXd) is effective and safe for treating certain advanced cancers that have a specific protein called HER2. HER2 can be found on the surface of some cancer cells, and identifying it helps doctors decide if certain targeted treatments might work.

The study involves people with various types of cancer, including bladder, bile duct, cervical, womb (endometrial), ovarian, and pancreatic cancers, as well as some other less common solid tumours. Importantly, it's for cancers that are considered advanced, meaning they have spread or can't be removed with surgery. Patients taking part will either have had previous treatments that stopped working, or they don't have other good treatment options available.

Researchers hope that T-DXd will show significant benefits for these patients and that its side effects will be manageable. This type of research is crucial for developing new treatments and improving the lives of people living with advanced cancers. The information gathered will help determine if T-DXd can become a standard treatment option for these specific HER2-expressing cancers.

Key takeaways

This study is testing a new drug (T-DXd) for several types of advanced cancer.
It focuses on cancers that have a specific protein called HER2.
The goal is to see how well the drug works and if it's safe for patients.
Participants must have advanced cancer that has progressed or has no other treatment options.
Regular hospital visits and health checks will be part of the study.

Who may be eligible?

This study is looking for adults aged 18 to 120 who have advanced cancer that has spread or cannot be removed. You would be considered if your cancer is in the bladder, bile duct, cervix, womb, ovary, or pancreas, or if it's another rare type of solid tumour. A key requirement is that your cancer cells must show the HER2 protein, which will be checked through special tests.

Your cancer must also have either not responded to previous treatments or you have no other suitable treatment options. It’s okay if you've already had treatments that target HER2. Scientists will also need to be able to measure your tumour to see if the treatment is working, and your organs (like your heart, kidneys, and liver) must be working well enough to safely receive the study drug.

However, you couldn't join the study if you have certain lung conditions, specifically a history of non-infectious pneumonitis or interstitial lung disease (ILD) that needed steroid treatment, or if you currently have ILD. The safety of participants is always the primary concern in such trials.

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.

Are you an adult aged 18 to 120?
Do you have advanced cancer that has spread or cannot be surgically removed?
Do tests show that your cancer cells have the HER2 protein?
Has your cancer progressed on previous treatments, or do you have no other treatment choices?
Are your major organs (heart, kidneys, liver) generally working well?
Do you have a history of specific lung conditions (like ILD) that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the investigational drug, trastuzumab deruxtecan (T-DXd), as an infusion. You will have regular visits to the hospital or clinic for these treatments and for various tests. These tests may include blood samples, urine tests, physical examinations, and scans (like CT scans) to check how the drug is affecting your cancer and your overall health. The study team will monitor you closely for any side effects.

There will be an initial screening period to make sure you meet all the criteria for joining. Once you start treatment, you'll continue to receive it as long as it's benefiting you and if side effects are manageable. Even after you stop receiving the treatment, you will have follow-up appointments so that researchers can continue to monitor your health and gather long-term information about the drug's effects. The total duration of your participation will depend on how you respond to the treatment and your overall health, but it could involve many months.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. A possible benefit of this study is that trastuzumab deruxtecan could help slow down or shrink your cancer, especially if other treatments haven't worked or are no longer an option. However, as with all medicines, there are potential side effects, which the study team will discuss in detail with you. These could include feeling sick, fatigue, or changes to your blood counts. You will be closely monitored throughout the study for any side effects. It’s important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (89)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Research Site
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Duarte, United States
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Santa Rosa, United States
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Chicago, United States
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Muncie, United States
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Boston, United States
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Middletown, United States
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Harrison, United States
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New York, United States
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New York, United States
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Durham, United States
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Houston, United States
Research Site
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Seattle, United States

Common questions

What is HER2 and why is it important for this study?

HER2 is a protein that can be found on the surface of some cancer cells. If your cancer has HER2, it might respond to specific treatments designed to target this protein, like the drug being tested in this study.

What does 'Phase 2 Study' mean?

Phase 2 is an early stage of clinical research where a new drug is tested in a larger group of patients than in Phase 1. The main goals are to see how effective the drug is and to gather more information about its safety and side effects.

Will I know if I am getting the study drug or a placebo?

This study is 'open-label,' which means you and your doctors will know that you are receiving the study drug, trastuzumab deruxtecan. No one in this study will receive a placebo.

Can I join if I've already had cancer treatment?

Yes, this study is for people whose cancer has progressed after previous treatments or who have no other satisfactory treatment options. Previous treatments, including those targeting HER2, are generally allowed.

What types of cancer are included in this study?

This study includes several types of advanced solid cancers, such as bladder, bile duct, cervical, womb (endometrial), ovarian, pancreatic, and some rare tumours, provided they show the HER2 protein.