Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors

This important study is exploring a new experimental medicine called ZN-A-1041 for people living with advanced solid tumours, including advanced breast cancer, where the cancer cells show a marker called HER2. The main goals are to understand how safe ZN-A-1041 is, how well people tolerate it, and if it could be an effective treatment. Researchers will test ZN-A-1041 on its own, and also in combination with some standard cancer therapies. The study is divided into different stages to carefully find the right dose and see how well combinations work. This research aims to find better ways to treat HER2-positive advanced cancers.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

210

Start

03 Sep 2020

Estimated completion

31 Aug 2027

Advanced Solid Tumors HER2-positive Breast Cancer

What is this study about?

This study is a clinical trial exploring a new potential treatment called ZN-A-1041. It's designed for people who have advanced solid tumours, which means cancers that have spread, and specifically those where the cancer cells have a particular protein called HER2. This HER2 protein can make cancer grow and spread more quickly, and treatments that target it are important.

The main purpose of this research is to safely test ZN-A-1041. Researchers want to understand if it's safe to take, what side effects it might cause, and how the body handles it. They will also look for early signs of whether ZN-A-1041 can help to control the cancer. They'll study ZN-A-1041 given by itself and also when it's combined with other common treatments used for HER2-positive cancers.

Because this is an early-stage study (called Phase 1), it's conducted in steps. First, they will give ZN-A-1041 on its own, starting with small doses and slowly increasing them in different groups of people until they find the safest and most effective dose. Then, they will test ZN-A-1041 in combination with other existing treatments, again carefully working to find the best dose for these combinations. Finally, more people will join to get these combination treatments, allowing researchers to gather more information on safety and initial effectiveness.

Key takeaways

New medicine (ZN-A-1041) for HER2-positive advanced solid cancers.
First stage of human testing, focusing on safety and correct dosage.
May involve ZN-A-1041 alone or combined with standard treatments.
Open to adults aged 18 and over with specific cancer history.
Close monitoring for safety and how the treatment works.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old. You must have advanced solid tumour cancer that has tested positive for the HER2 protein, and your cancer must have either progressed after previous treatments, or you've already had certain initial treatments for advanced disease. You'd also need to be generally well enough to participate, as determined by a simple health check, and doctors would expect you to live for at least another six months.

It's important that you haven't taken part in another experimental drug or device study in the four weeks before this trial starts. If you have any spots on your brain (brain metastases), you might still be able to join, as long as they don't need immediate treatment like surgery or radiation, or high-dose steroid medication at the time you join the study. The study is open to both men and women.

Quick self-check

Am I at least 18 years old?
Do I have advanced solid cancer that is HER2-positive?
Has my cancer progressed after previous treatments, or have I had certain initial treatments?
Am I generally well enough for a study, as my doctor would assess?
Have I not participated in another experimental drug study in the last 4 weeks?

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

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to check if you meet all the requirements. If you do, you would receive the study treatment, which involves taking ZN-A-1041, possibly with other standard cancer medicines. ZN-A-1041 is usually given as capsules you swallow, and the other medicines are given as injections or through a drip into your vein.

Throughout the study, you would have regular visits to the hospital or clinic. These visits would include blood tests, scans, and physical examinations to keep an eye on your health, how you're reacting to the treatment, and how your cancer is responding. The number of visits and the types of assessments would vary depending on your treatment phase and how you're doing. There will also be follow-up appointments after your treatment period to monitor your longer-term health. The total duration of your participation would depend on your response to treatment and the study phase you are in, but the researchers will explain this fully.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to a new treatment like ZN-A-1041 before it's widely available. This new treatment might be effective where others haven't worked as well. However, there are also potential risks; new treatments can have unknown side effects, or may not work for everyone. You will be closely monitored for any side effects or changes in your health. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (36)

Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - Aoa
Tucson, United States
TOI Clinical Research
Cerritos, United States
UCSF Helen Diller Family CCC
San Francisco, United States
Dana Farber Cancer Institute
Boston, United States
University of Michigan Hospital
Ann Arbor, United States
Barbara Ann Karmanos Cancer Institute
Detroit, United States
Duke University School of Medicine
Durham, United States
MD Anderson Cancer Center
Houston, United States
Geelong Hospital
Geelong, Australia
Sunshine Hospital
St Albans, Australia
EDOG - Institut Claudius Regaud - PPDS
Toulouse, France
Centre Georges Francois Leclerc
Dijon, France

+24 more sites — see the official record for the full list.

Common questions

What is HER2-positive cancer?

HER2-positive means cancer cells have too much of a protein called HER2, which helps them grow. Treatments can target this protein.

What does 'Phase 1' study mean?

Phase 1 is the first step where a new medicine is tested in people. The main goal is to check its safety and find the right dose.

Will I receive the new medicine alone or with other treatments?

In this study, some people will receive the new medicine, ZN-A-1041, on its own, while others will get it combined with standard cancer treatments.

Can I still join if I have cancer spread to my brain?

Yes, you might be able to, as long as these brain spots don't need urgent treatment like surgery or radiation at the time of joining.

What kind of cancer does this study focus on?

This study is for people with advanced solid tumours that are HER2-positive, including advanced breast cancer.