Active not recruitingPHASE1INTERVENTIONAL

A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors

This research study is investigating a new combination treatment called DS-1103a, alongside another medicine called T-DXd. It's for people who have advanced solid tumors that have spread or can't be removed with surgery. The main goal is to understand how safe this new combination treatment is and if it can help slow down or shrink the cancer. Researchers will also be looking at how well patients tolerate the treatment and if it has any positive effects on their health. This is an early-stage study, meaning it's the first time this specific combination is being tested in humans.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Daiichi Sankyo

Enrolment target

108

Start

30 May 2023

Estimated completion

15 May 2030

Advanced Solid Tumor

What is this study about?

This study is exploring a new combination treatment for people living with advanced solid tumours. "Advanced solid tumours" means cancers that have spread to other parts of the body or can't be removed by surgery. The treatment involves a new medicine called DS-1103a, given together with T-DXd, which is another anti-cancer therapy.

DS-1103a is a special type of antibody, like a guided missile, designed to target specific signals on cancer cells. Researchers hope that by blocking these signals, DS-1103a can help the body fight the cancer more effectively when combined with T-DXd. This is an early study, called a 'Phase 1' trial, which means it's one of the first times this specific combination is being tested in people. The main focus at this stage is to make sure the treatment is safe and to find the right dose. They will also start to look for any signs that the treatment is effective against the cancer.

The findings from this study will help doctors understand DS-1103a better. If it shows promise in terms of safety and effectiveness, it could lead to further research and potentially new treatment options for people with advanced solid tumours in the future.

Key takeaways

This study tests a new combination treatment for advanced solid tumours.
The treatment involves two drugs: DS-1103a and T-DXd.
It's for people with HER2-positive or HER2-mutated cancers.
The main goals are to check safety and find the best dose.
Regular hospital visits and health checks are part of participating.

Who may be eligible?

To join this study, you must be at least 18 years old and have an advanced solid tumour that has a specific marker called HER2. This means your tumour either produces more HER2 than usual or has a specific change (mutation) in the HER2 gene. Unfortunately, if your cancer is not HER2-positive, you won't be able to join this particular study.

You also need to be well enough to take part, meaning you can carry out most of your usual daily activities. Your vital organs, like your heart and bone marrow, need to be working well. The doctors will do some tests to check this, including scans of your tumour to see if it can be measured clearly.

Finally, you must be willing to have regular medical checks, follow the study instructions, and if you are able to have children, agree to use effective contraception during the study and for a period afterwards.

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 an advanced solid tumour?
Has your doctor confirmed your tumour is HER2-positive or has a HER2 gene change?
Are you generally well enough to go about your daily activities?
Are you willing to have regular hospital visits, tests, and follow study rules?
If you can have children, are you willing to use effective contraception during and after the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic for medical checks, blood tests, and to receive the study medications. These visits will help the doctors monitor your health and how you are responding to the treatment. You will receive the study drugs according to a set schedule.

Throughout the study, you will have scans, likely CT or MRI, to see how your tumour is reacting to the treatment. You will also be asked to provide a small sample of your tumour tissue. After you finish the treatment part of the study, there will be follow-up appointments to continue monitoring your health and any long-term effects of the treatment. The total duration of your participation will depend on how you respond to the treatment and the study's design.

Potential risks and benefits

Taking part in any medical study has 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 the treatment will work for you. There is always a risk of side effects from the new medication, some of which could be serious. The study team will carefully monitor you for any side effects and provide care. You can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Florida Cancer Specialists
Verified postcode
Sarasota, United States
Lifespan Cancer Institute
Verified postcode
Providence, United States
University of Utah
Verified postcode
Salt Lake City, United States
NEXT Oncology
Verified postcode
Fairfax, United States
Princess Margaret Cancer Centre, University Health Network
Verified postcode
Toronto, Canada
Oncopole - Institut Claudius Regaud
Verified postcode
Toulouse, France
Centre Léon Bérard
Verified postcode
Lyon, France
Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain

Common questions

What is a 'solid tumour'?

A solid tumour is a lump of abnormal tissue that usually doesn't contain cysts or liquid areas. Most cancers are solid tumours.

What does 'advanced' mean in this study?

In this context, 'advanced' means the cancer has either spread to other parts of your body (metastatic) or cannot be removed by surgery.

What is HER2?

HER2 is a protein that can be found on the surface of some cancer cells. When there's too much HER2, it can make cancer grow and spread more quickly. Treatments can target HER2.

Will I know if I'm getting the new drug or something else?

Because this study is looking at a specific combination of DS-1103a and T-DXd, all participants will receive both medications.

What is a 'Phase 1' study?

A Phase 1 study is an early stage clinical trial focused on checking if a new treatment is safe for people and finding the right dose. It's not primarily about seeing how well it works yet, but they will look for signs of benefit.