ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
This research is looking into a new medicine called ELVN-002. It's being tried alongside standard treatments like trastuzumab and chemotherapy for adults with advanced cancers that are HER2-positive. This includes certain types of breast, stomach, bowel, and other solid tumours. The study has different parts. Some parts focus on checking the new drug's safety, how the body handles it, and finding the best dose. Other parts will also see how effective ELVN-002 is when combined with other medicines. This is a Phase 1 study, meaning it's an early stage of testing new treatments in people.
At a glance
What is this study about?
This study is exploring a new drug, ELVN-002, for adults who have advanced cancer where their tumours show high levels of a protein called HER2. This is often called HER2-positive cancer and can include certain types of breast cancer, stomach cancer, bowel cancer, and other solid tumours.
The main aim of this research is to see how safe ELVN-002 is, how well people tolerate it, and to figure out the best dose when it's given with other established treatments like trastuzumab and various chemotherapy drugs. Because it's a Phase 1 study, it's an early step in testing new medicines in people. The researchers also want to get an early idea of whether the drug helps shrink tumours or slow their growth.
The study is divided into several sections. Some sections will focus on checking safety and dosage when ELVN-002 is combined with trastuzumab alone. Other sections will look at ELVN-002 with trastuzumab and different chemotherapy combinations, depending on the type of cancer. For example, specific chemotherapy drugs will be tested with ELVN-002 for HER2-positive bowel cancer and breast cancer. All these steps help researchers understand the new drug better before it can be studied in larger groups of people.
Key takeaways
- New drug ELVN-002 is being tested for advanced HER2-positive cancers.
- It's being combined with existing treatments like trastuzumab and chemotherapy.
- The study aims to find a safe dose and see how well it works.
- This is an early-stage (Phase 1) study.
- You must have a 'HER2-positive' cancer and specific prior treatments to be eligible.
- Participation involves regular visits for checks and tests.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or over and have a type of cancer that is HER2-positive. This means your cancer cells have a particular protein called HER2. Your cancer must also be advanced, meaning it has spread locally, come back after treatment, or is metastatic (spread to other parts of the body). You'll need to have had certain previous treatments for your cancer, which will depend on the type of cancer you have.
For example, if you have HER2-positive bowel cancer, you would need to have had prior treatments like fluoropyrimidine, oxaliplatin, and irinotecan-based medicines. If you have HER2-positive breast cancer, you would typically have had treatments such as taxane, pertuzumab, trastuzumab, and possibly fam-trastuzumab deruxtecan. For stomach cancer, prior treatment with trastuzumab/platinum fluorouracil and T-DXd is usually required. For other HER2-positive cancers, you need to have already received at least one prior treatment for your advanced cancer.
Critically, your doctors will need to confirm that your specific cancer meets the HER2-positive criteria through special tests on your tumour tissue. Also, for some cancer types like bowel cancer, specific genetic mutations (like RAS or BRAF) must not be present. The study team will review all your medical information to see if you meet these detailed requirements.
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 old or older?
- Do you have an advanced, HER2-positive solid tumour (like breast, stomach, or bowel cancer)?
- Have you had previous treatments for your cancer?
- Are you currently well enough to consider a clinical trial?
- Are you able to travel to the study site for regular appointments?
- Do you understand that this is an early-stage study of a new medicine?
What does participation involve?
If you join this study, you'll receive the new drug ELVN-002 alongside other approved cancer medicines like trastuzumab and specific chemotherapy treatments. You'll have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits will help the doctors assess the safety of the treatments and see if they are working. The exact number of visits, frequency of assessments (like blood tests and scans), and the total duration of your participation will depend on which part of the study you are in and how you respond to the treatment. This will be explained in detail by the study team.
Potential risks and benefits
Locations (31)
- BRCR Medical Center Inc.Verified postcodePlantation, United States
- Washington UniversityVerified postcodeSt Louis, United States
- NEXT VirginiaVerified postcodeFairfax, United States
- Cliniques Universitaires Saint-LucVerified postcodeBrussels, Belgium
- CHU de LiègeVerified postcodeLiège, Belgium
- GZA Ziekenhuizen - Campus Sint-AugustinusVerified postcodeWilrijk, Belgium
- Institut du Cancer de Montpellier - Val D'AurelleVerified postcodeMontpellier, France
- CHU de PoitiersVerified postcodePoitiers, France
- Institut de Cancérologie de l'OuestVerified postcodeSaint-Herblain, France
- Institut de Cancérologie Strasbourg EuropeVerified postcodeStrasbourg, France
- Azienda Ospedaliero-Universitaria Renato DulbeccoVerified postcodeCatanzaro, Italy
- Istituto Europeo di OncologiaVerified postcodeMilan, Italy
Common questions
What does 'HER2-positive' mean?
It means your cancer cells have high levels of a protein called HER2, which can make them grow faster. Treatments that target HER2 can sometimes be effective.
What is a 'Phase 1' study?
Phase 1 is an early stage of testing a new drug in a small group of people. The main goals are to check for safety, find the right dose, and see how the body handles the medicine.
Will I definitely get the new drug ELVN-002?
Yes, in this study, all participants will receive the new drug ELVN-002 along with other standard treatments. There isn't a placebo group.
What are 'solid tumours'?
Solid tumours are cancers that form a lump or mass of tissue. This study is looking at HER2-positive solid tumours, including breast, stomach, and bowel cancers.
Can I stop participating in the study at any time?
Yes, you have the right to leave the study at any point, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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