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 clinical trial looks at a new experimental medicine called ZN-A-1041 for adults with advanced or secondary HER2-positive cancer, particularly breast cancer. HER2 is a protein that can cause cancer cells to grow and divide quickly. The main goal is to find safe doses of ZN-A-1041, which is taken as a capsule. Researchers also want to see how well it works. In different parts of the study, participants may take ZN-A-1041 on its own or combined with standard HER2 treatments such as Herceptin, Perjeta, Kadcyla, or Enhertu. The trial is open to people whose cancer has returned or progressed after previous treatment. It also welcomes people whose cancer has spread to the brain, provided they do not need urgent surgery or radiotherapy. The findings will help doctors understand whether this new treatment can improve care in the future.
Överblick
Vad handlar denna studie om?
Some types of cancer cells have unusually high levels of a protein called HER2 on their surface. This protein acts like an accelerator pedal, encouraging cancer cells to grow and spread quickly. While there are several effective treatments for HER2-positive breast cancer and other HER2-positive tumours, cancers can eventually learn to resist these drugs. It can also be very difficult to treat HER2-positive cancer if it spreads to the brain, as many standard medicines cannot easily reach that area.
This trial is testing an experimental targeted drug known as ZN-A-1041. It comes as a capsule you swallow. The aim of the trial is to find out if ZN-A-1041 can help control advanced HER2-positive tumours safely, either on its own or when combined with well-known cancer drugs like trastuzumab, pertuzumab, T-DM1, or T-DXd.
The study has three parts. In the first part (Phase 1a), small groups of participants take ZN-A-1041 alone at slowly increasing doses to find the highest safe dose. In the second part (Phase 1b), ZN-A-1041 is tested together with standard medicines to make sure the combinations are safe. In the final part (Phase 1c), more people receive the best combination doses to see how well the treatments shrink or slow down tumour growth.
Viktiga punkter
- Tests a new targeted capsule, ZN-A-1041, for advanced HER2-positive cancers.
- Aims to find the safest dose when used alone or with standard cancer medicines.
- Welcomes participants whose cancer has spread to the brain, provided it is stable.
- Designed for people whose cancer has grown despite previous standard treatments.
- Participation is entirely voluntary, and there is no placebo.
Vem kan vara berättigad?
This trial is for adults aged 18 and over who have an advanced or secondary (metastatic) solid tumour that is HER2-positive, most commonly breast cancer. To take part, you must have already tried certain standard HER2 treatments that have stopped working, and your doctor must feel you are well enough to carry out daily activities and light tasks.
People whose cancer has spread to the brain may also take part, which is not always possible in clinical trials. However, the brain tumours must be stable or not in need of immediate emergency treatment, such as urgent surgery, radiation therapy, or high-dose steroids.
You will not be able to join if you have taken part in another clinical trial testing an experimental drug or medical device within the last four weeks. Your hospital doctor will carry out tests to make sure joining the trial is safe and appropriate for your health.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- I am aged 18 or older.
- I have been diagnosed with an advanced or metastatic HER2-positive cancer.
- I have already received standard treatments (such as Herceptin or similar drugs) that have stopped working.
- I am well enough to look after myself and do light everyday activities.
- I have not taken an experimental drug in another clinical trial within the last 4 weeks.
- Any tumours in my brain are stable and do not need emergency surgery or radiation.
Vad innebär deltagande?
Taking part begins with a screening stage, where the study team checks your health using blood tests, heart scans, and imaging scans (like CT or MRI). If you join, you will be given ZN-A-1041 capsules to swallow, either on their own or alongside standard cancer treatments given through a drip (infusion) into a vein. You will need to visit the hospital regularly for health checks, blood tests, and scans so the team can monitor how your body responds to the medicine. Treatment continues as long as the medicine is helping and side effects remain manageable. After you finish the treatment, the study team will stay in touch to check on your recovery and wellbeing.
Potentiella risker och fördelar
Platser (36)
- Arizona Clinical Research Center, Inc.;Hematology Oncology Physicians - AoaVerifierat postnummerTucson, USA
- TOI Clinical ResearchVerifierat postnummerCerritos, United States
- UCSF Helen Diller Family CCCVerifierat postnummerSan Francisco, USA
- Dana Farber Cancer InstituteVerifierat postnummerBoston, USA
- University of Michigan HospitalVerifierat postnummerAnn Arbor, USA
- Barbara Ann Karmanos Cancer InstituteVerifierat postnummerDetroit, USA
- Duke University School of MedicineVerifierat postnummerDurham, USA
- MD Anderson Cancer CenterVerifierat postnummerHouston, USA
- Geelong HospitalVerifierat postnummerGeelong, Australien
- Sunshine HospitalVerifierat postnummerSt Albans, Australia
- EDOG - Institut Claudius Regaud - PPDSVerifierat postnummerToulouse, Frankrike
- Centre Georges Francois LeclercVerifierat postnummerDijon, Frankrike
Vanliga frågor
Will I receive a dummy treatment (placebo)?
No. This is an open-label study, meaning there is no placebo. Everyone who takes part will receive the active study medicine, either alone or with standard cancer drugs.
Can I take part if my cancer has spread to my brain?
Yes, people with brain metastases may be eligible, as long as the tumours do not need urgent surgery, radiotherapy, or steroid medication right away.
How do I take the trial drug?
ZN-A-1041 comes as a capsule that you swallow. If you are also receiving combination drugs, those are usually given as an infusion into a vein at the clinic.
Do I have to pay to take part?
No, the study medicine and any extra trial-related tests are provided free of charge. Some studies also help with travel expenses to and from the hospital.
What happens if I want to stop the trial?
You are free to leave the trial at any time for any reason. Your medical team will respect your decision and discuss other available treatment options with you.
Hur du får reda på mer
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