RecruitingPHASE2INTERVENTIONAL

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors

This research is testing a new medicine called HER3-DXd for people who have advanced solid tumours that are difficult to treat or have spread. These are cancers that doctors can't remove with surgery. The study is looking at how effective this new medicine is and if it has any side effects. It includes people with various cancers such as melanoma, head and neck cancer, stomach cancer, ovarian cancer, cervical cancer, womb cancer, bladder cancer, throat cancer, pancreatic cancer, prostate cancer, non-small cell lung cancer, and breast cancer. The main goal is to find out if HER3-DXd can shrink these tumours or stop them from growing. Researchers will also be checking the safety of the treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Daiichi Sankyo

Enrolment target

740

Start

26 Feb 2024

Estimated completion

10 Oct 2028

Advanced Solid Tumor Melanoma Head and Neck Cancer Gastric Cancer Ovarian Carcinoma Cervical Cancer Endometrial Cancer Bladder Cancer Esophageal Cancer Pancreatic Carcinoma Prostate Cancer Non-small Cell Lung Cancer (NSCLC)Lung Cancer Breast Cancer

What is this study about?

This study is about a new medicine called HER3-DXd. It's being tested in people who have specific types of advanced solid tumours. This means the cancer has either grown quite a bit locally, making it hard to remove, or it has spread to other parts of the body (this is called metastatic cancer). For these patients, their current treatments haven't worked well enough.

The main aim of this research is to see how effective HER3-DXd is at treating these cancers. Researchers want to know if it can shrink the tumours or stop them from growing. They are also very interested in understanding how safe the medicine is and what side effects it might cause. By gathering this information, doctors hope to learn if HER3-DXd could be a new treatment option in the future for people with these difficult-to-treat cancers.

The study involves people with many different types of cancer, including melanoma, head and neck cancer, stomach cancer, ovarian cancer, cervical cancer, womb cancer, bladder cancer, throat cancer, pancreatic cancer, prostate cancer, lung cancer, and breast cancer. It's important to understand that this is an early-stage study, meaning it's one of the first times this medicine is being given to a larger group of people. The results will help doctors decide if further research into HER3-DXd is worthwhile.

Key takeaways

This study is testing a new drug, HER3-DXd, for advanced solid tumours.
It aims to see how well the drug works and if it's safe.
Many different cancer types are included, like melanoma, lung, and breast cancer.
Participants must have advanced cancer that hasn't responded to previous treatments.
You will receive the new medicine and have regular check-ups.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have an advanced solid tumour that doctors can't remove with surgery, or a cancer that has spread. You might be eligible if your cancer has already been treated with at least one other type of anticancer medicine, and it hasn't responded as hoped.

For example, if you have melanoma, it must have progressed after treatments like immunotherapy. If you have a specific type of head and neck cancer, it needs to have progressed after earlier systemic treatments, including immunotherapy.

There are also specific requirements about the type of cancer you have and the treatments you've already received. The study team will need to check your medical records and may ask for a small sample of your tumour tissue to see if it meets the study criteria. They will explain everything clearly during your first visit.

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 at least 18 years old?
Do you have advanced cancer that cannot be removed by surgery, or has spread?
Has your cancer been treated with at least one other treatment that wasn't fully effective?
Are you willing to provide a sample of your tumour tissue?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked to sign a special form that shows you understand the study and agree to participate. This is called informed consent. You'll also be asked to provide a sample of your tumour tissue, either from a past biopsy or a new one if needed.

The study involves receiving the HER3-DXd medication. You will have regular appointments with the study team, where they will check your health, do physical exams, take blood samples, and perform scans to see how the treatment is affecting your cancer. These visits will be frequent at first and then less often over time.

We don't have details on the exact number of visits, duration of treatment, or specific follow-up period in this summary, but the study team will provide a full schedule during your initial consultation. They will closely monitor you throughout the study to make sure you are safe and that the treatment is working effectively.

Potential risks and benefits

Taking part in a clinical trial might offer some potential benefits, such as access to a new treatment that isn't widely available yet, which could help manage your cancer. However, there's no guarantee the treatment will work for you, and it might not be better than standard care. Like all medicines, HER3-DXd could cause side effects, some of which might be serious. The study team will explain all known risks and carefully monitor you for any problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (85)

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

City of Hope
Verified postcode
Duarte, United States· Recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
AdventHealth Medical Group Oncology Research at Celebration
Verified postcode
Kissimmee, United States· Recruiting
University of Illinois Cancer Center
Verified postcode
Chicago, United States· Recruiting
Johns Hopkins University
Verified postcode
Baltimore, United States· Recruiting
Health Partners Frauenshuh Cancer Center
Verified postcode
Saint Louis Park, United States· Recruiting
Health Partners Cancer Center at Regions Hospital
Verified postcode
Saint Paul, United States· Recruiting
Washington University, School of Medicine
Verified postcode
St Louis, United States· Recruiting
Roswell Park Cancer Institute IDS
Verified postcode
Buffalo, United States· Recruiting
Memorial Sloan Kettering Hospital
Verified postcode
New York, United States· Recruiting
SCRI Oncology Partners
Verified postcode
Nashville, United States· Recruiting
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting

Common questions

What is HER3-DXd?

HER3-DXd is the name of a new medicine being tested in this study for specific types of advanced cancers.

What does 'locally advanced unresectable' mean?

It means the cancer has grown quite a bit in one area and doctors can't remove it with surgery.

What does 'metastatic' mean?

It means the cancer has spread from where it started to other parts of your body.

Will I definitely get the new medicine?

Yes, if you join this study, you will receive HER3-DXd, as it is testing this medicine as a single treatment.

Can I stop participating if I want to?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your future medical care.

How to find out more

Daiichi Sankyo Contact for Clinical Trial Information

CTRinfo@dsi.com 9089926400 Official trial record

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