Active not recruitingPHASE2INTERVENTIONAL

A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2

This research study is looking at a new drug called disitamab vedotin (DV) for people with advanced cancers that have grown or spread. This includes head and neck, non-small cell lung, ovarian, and endometrial cancers. To join, your cancer must have a special marker called HER2 and you must have had previous treatments. DV is an 'antibody-drug conjugate' that is designed to find and kill cancer cells. Everyone in the study will receive DV every two weeks. The main goals are to find out if DV helps treat these cancers, how safe it is, and what side effects it might cause. This is a Phase 2 study, meaning it's still in the earlier stages of testing new drugs.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrolment target

120

Start

14 Nov 2023

Estimated completion

31 May 2028

Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Endometrial Neoplasms Head and Neck Neoplasms

What is this study about?

This study is about exploring a new treatment called disitamab vedotin, or DV, for certain serious cancers. These include advanced head and neck, a type of lung cancer called non-small cell lung cancer, ovarian cancer, and endometrial cancer. When a cancer grows very large or spreads to different parts of the body, it’s called advanced or metastatic cancer. The study is specifically for people whose cancer has a special feature called HER2, which is like a particular target on the cancer cells.

Disitamab vedotin is a type of medicine called an 'antibody-drug conjugate' (ADC). You can think of an ADC like a carefully guided missile. The 'antibody' part is designed to find and attach to cancer cells that have the HER2 target. Once it's attached, the 'drug' part is delivered directly to the cancer cell to kill it, hopefully without harming too many healthy cells. By giving the drug directly to the cancer cells, scientists hope it will be more effective and have fewer side effects than traditional chemotherapy.

This study will give the new drug, DV, to all participants every two weeks. The main reasons for doing this study are to see how well DV works in shrinking or controlling these specific types of cancer, to understand how safe it is, and to identify any side effects that might occur. This information helps doctors decide if DV could become a new treatment option in the future. Remember, this is an experimental drug, meaning it's still being tested and is not yet a standard treatment.

Key takeaways

This study is for advanced head and neck, non-small cell lung, ovarian, or endometrial cancers.
The new drug, disitamab vedotin, targets a specific marker on cancer cells called HER2.
It's an experimental treatment, aiming to see how well it works and if it's safe.
You must have already received some previous cancer treatments to be eligible.
You will receive the study drug every two weeks, and your health will be closely monitored.

Who may be eligible?

The study is looking for adults aged 18 and older. You might be able to join if you have advanced head and neck cancer, non-small cell lung cancer, ovarian cancer, or endometrial cancer. For most of these cancers, your disease must have grown or spread, and you must have already tried some other treatments.

Importantly, your cancer needs to have a specific marker called HER2. This is like a signal on your cancer cells that the study drug is designed to target. There are also specific requirements for the types of previous treatments you've had, depending on your particular cancer. For example, some people will need to have tried platinum-based chemotherapy, and some with non-small cell lung cancer will have needed to try a recent immunotherapy or targeted drugs if their cancer has certain changes (mutations). People with ovarian cancer will likely need to have cancer that has returned within 6 months after platinum-based treatment.

This detailed setup helps make sure the study includes people who are most likely to benefit from this specific new drug, or where the drug can deliver the most useful information. Your medical team will carefully check all your past treatments and your specific cancer details to see if you meet all the criteria.

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 18 years of age or older?
Do you have advanced (grown or spread) head and neck, non-small cell lung, ovarian, or endometrial cancer?
Has your cancer been tested and confirmed to have the HER2 marker?
Have you already received some previous treatments for your cancer?
Are you able to attend regular clinic visits for treatment and monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study drug, disitamab vedotin, once every two weeks. This drug will be given into your vein, likely through a drip. Throughout the study, you will have regular visits to the clinic. During these visits, the doctors and nurses will monitor your health, check for any side effects, and do various tests. These tests might include blood tests, scans (like CT scans or MRI scans) to see how your cancer is responding, and physical examinations. You will also be asked about how you are feeling and any symptoms you are experiencing. The total length of your participation in the study will depend on how your cancer responds to the treatment and your general health, but you will continue treatment as long as it is working and you are tolerating it well.

Potential risks and benefits

Taking part in any clinical trial involves both possible benefits and risks. The potential benefit of this study is that the experimental drug, disitamab vedotin, might help shrink or control your cancer, or slow its growth, especially if other treatments haven't worked well for you. However, as with any new medicine, there are potential risks and side effects. These will be explained to you in detail by the study team, and they will carefully monitor you throughout the trial. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (94)

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

Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Verified postcode
Chandler, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Verified postcode
Gilbert, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Verified postcode
Glendale, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Verified postcode
Mesa, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Verified postcode
Mesa, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Verified postcode
Phoenix, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Verified postcode
Scottsdale, United States
Valkyrie Clinical Trials(Additional Suite)
Verified postcode
Los Angeles, United States
Valkyrie Clinical Trials
Verified postcode
Los Angeles, United States
University of California Davis Comprehenvise Cancer Center
Verified postcode
Sacramento, United States
University of California Davis Medical Center
Verified postcode
Sacramento, United States
Providence Medical Foundation
Verified postcode
Santa Rosa, United States

Common questions

What is an 'advanced' or 'metastatic' cancer?

This means the cancer has either grown very large in its original spot or has spread from its original location to other parts of your body.

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

HER2 is a type of protein that can be found on the surface of some cancer cells. In this study, it acts like a target that the new drug is designed to find and attack.

Is disitamab vedotin a chemotherapy drug?

It's different from traditional chemotherapy. It's a targeted drug called an 'antibody-drug conjugate' that is designed to specifically deliver a cancer-killing medicine to cells that have the HER2 marker.

What does 'Phase 2' mean for a clinical trial?

Phase 2 means the drug has already been safely tested in a small number of people, and now researchers want to see if it works well against the cancer and further evaluate its safety in a larger group.

What if I get side effects from the drug?

The study team will monitor you closely for any side effects. If you experience them, they will provide care and support to manage them, and adjust your treatment if necessary.