RecruitingPHASE2INTERVENTIONAL

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

This clinical trial is for people with advanced breast or stomach cancers, including those where the cancer has spread (metastatic). The study is specifically for cancers that have a marker called HER2, which can make them grow or spread more quickly. Researchers are testing a new combination of two drugs: disitamab vedotin, an experimental drug designed to target and kill cancer cells, and tucatinib, a drug already approved in some countries. The main goals are to find out how safe and effective this two-drug combination is, and to understand any side effects people might experience. This is a Phase 2 study, which means it builds on earlier research to investigate the treatment in a larger group of patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrolment target

172

Start

20 May 2024

Estimated completion

28 Jul 2029

Breast Neoplasms Gastroesophageal Junction Adenocarcinoma HER2 Low Breast Neoplasms HER2 Positive Breast Neoplasms Stomach Neoplasms Triple Negative Breast Neoplasms Metastatic Breast Cancer Metastatic Gastric Cancer Advanced Breast Cancer Advanced Gastric Cancer

What is this study about?

This study is a clinical trial, which means it's a carefully planned medical research study involving people. The main focus is on certain types of advanced cancer, specifically breast cancer and stomach cancer, including cancer that has grown significantly in one area or spread to other parts of the body (called advanced or metastatic cancer). These cancers can be challenging to treat, especially when standard treatments are no longer working well.

The researchers are particularly interested in cancers that have a specific feature called HER2. This is like a signal on the cancer cells that can help them grow and spread. For patients with these HER2-positive cancers, especially when they are advanced, there aren't many treatment options left. This study is trying to find a new way to tackle these cancers by combining two particular drugs.

One of the drugs is called disitamab vedotin. This is an experimental medicine, which means it's still being tested and is not yet available for general use. It's a clever type of drug called an antibody-drug conjugate (ADC). Think of it like a guided missile: it's designed to specifically find and stick to cancer cells with the HER2 marker, and then deliver a powerful drug directly to those cells to kill them, while hopefully causing less harm to healthy cells. The other drug in this combination is tucatinib, which is already approved for cancer treatment in some parts of the world. By combining these two drugs, doctors hope to get a stronger and more effective treatment against these specific types of cancer. The study will look closely at how well this combination works and what side effects people might have.

Key takeaways

This study is testing new drug combinations for advanced breast or stomach cancer.
It focuses on cancers with a specific marker called HER2.
One drug is new and experimental, the other is approved for other uses.
The main goals are to find out how safe and effective the combination is, and what side effects occur.
It's for patients whose cancer has progressed on, or can't tolerate, standard treatments.
Patient safety and monitoring for side effects are very important.

Who may be eligible?

To be able to take part in this study, you would need to meet certain conditions. Firstly, you must be 18 years or older, and generally well enough to participate in a clinical trial activities, meaning you can carry out most of your normal daily activities without much trouble.

The study is specifically for people diagnosed with advanced breast cancer or stomach cancer where the cancer has grown or spread, and it must have the HER2 marker. You would also need to have tried standard treatments already, and unfortunately, your cancer either didn't respond or got worse, or you couldn't tolerate those treatments.

There are also specific requirements depending on the type of breast cancer and previous treatments you've had. For example, if your breast cancer has a low amount of the HER2 marker, or if you have a known BRCA gene mutation, there are further details about what prior treatments you must have received or failed. The study team will carefully check all these details with you to see if this trial might be a suitable option.

Quick self-check

Are you 18 years or older?
Do you have advanced breast or stomach cancer?
Does your cancer have the HER2 marker?
Have you already tried and stopped other standard cancer treatments because they didn't work or you couldn't tolerate them?
Are you generally well enough to manage daily activities?
Are you able to attend regular clinic appointments and tests?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study will involve several visits to the clinic over a period of time. Initially, you will have tests to make sure you are suitable for the study. If you join, you will receive the study medications, disitamab vedotin and tucatinib, over a schedule that the study doctors will explain. You will have regular check-ups, blood tests, and scans to monitor your health, how the treatment is affecting your cancer, and to look for any side effects. The study will involve different stages, first finding the best dose, and then testing that dose in more people. The total duration of your participation will depend on how you respond to the treatment and the stage of the study you are in, but the team will discuss the expected timeline with you. Regular follow-up appointments will continue even after you stop taking the study drugs.

Potential risks and benefits

Like all clinical trials, there are potential benefits and potential risks to consider. A potential benefit could be access to a new treatment combination that might help control your cancer, especially if standard treatments haven't worked or are no longer an option. However, as the drugs are still being studied, it's not guaranteed that they will work for you or that they will be better than existing treatments. Potential risks include experiencing side effects from the study drugs, which could range from mild to serious and would need careful monitoring by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (141)

Banner-University Medical Center Tucson Campus
Tucson, United States· Recruiting
Banner-University Medical Center Tucson Campus
Tucson, United States· Recruiting
The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal
Tucson, United States· Recruiting
University of Arizona Cancer Center - North Campus
Tucson, United States· Recruiting
The University of Arizona Cancer Center-Main
Tucson, United States· Recruiting
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, United States· Recruiting
UC Irvine Medical Center
Orange, United States· Recruiting
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, United States· Recruiting
UCLA Department of Medicine - Hematology & Oncology
Santa Monica, United States· Recruiting
UCLA Hematology/Oncology - Parkside
Santa Monica, United States· Recruiting
Colorado West Healthcare System, dba Community Hospital
Grand Junction, United States· Not yet recruiting
Colorado West Healthcare, dba Grand Valley Oncology
Grand Junction, United States· Not yet recruiting

+129 more sites — see the official record for the full list.

Common questions

What is HER2-positive cancer?

HER2 is a protein on the surface of some cancer cells that can make them grow and spread faster. Cancers with a lot of HER2 are called HER2-positive.

What does 'advanced' or 'metastatic' cancer mean?

This means the cancer has either grown significantly in one area and can’t be removed by surgery, or it has spread from where it started to other parts of the body.

Are the drugs in this study approved treatments?

Disitamab vedotin is an experimental drug, meaning it's still being tested. Tucatinib is approved to treat certain cancers in some countries, but its use in this specific combination and for these cancers is new and being studied.

What is a 'side effect'?

A side effect is any unwanted effect or reaction a medicine causes in your body, in addition to its main purpose of treating the disease.

How long would I be in the study if I participate?

The total time you’d be in the study can vary. It depends on how you respond to the treatment and the stage of the study. The study team will discuss the expected duration with you.

How to find out more

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021 Official trial record

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