Study of ELVN-002 with Trastuzumab and Chemotherapy for Patients with Advanced HER2+ Solid Tumors, Colorectal Cancer, and Breast Cancer

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What is this study about?

This clinical trial is focused on studying the treatment of advanced stage HER2-positive cancers, specifically solid tumors, colorectal cancer, and breast cancer. The study involves a new medication called ELVN-002, which is being tested in combination with another drug called trastuzumab. In some cases, additional chemotherapy drugs such as capecitabine, oxaliplatin, fluorouracil, leucovorin, eribulin, and paclitaxel may also be used. The purpose of the study is to evaluate the safety and tolerability of these combinations in patients with advanced stage HER2-positive cancers.

Participants in the study will receive the treatment combinations, and their health will be monitored to assess how well they tolerate the medications. The study will also help determine the recommended doses of ELVN-002 when used with trastuzumab and chemotherapy. The trial is divided into two phases: Phase 1a, which focuses on safety and dose determination, and Phase 1b, which continues to evaluate safety and tolerability in a broader group of patients.

The study will involve regular check-ups and monitoring to ensure the safety of participants. This includes looking for any side effects or changes in health status. The trial aims to provide valuable information on the potential benefits and risks of using ELVN-002 in combination with other treatments for HER2-positive cancers. The estimated completion date for the study is in 2027.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, type of cancer, and health status.

Participants must have a documented solid tumor and HER2 positive disease.

2 initial treatment phase

The initial phase involves the administration of ELVN-002 combined with trastuzumab.

This phase aims to evaluate the safety and determine the recommended dose of ELVN-002.

3 combination treatment phase

Participants with advanced stage HER2 positive colorectal cancer receive ELVN-002, trastuzumab, and chemotherapy, which may include capecitabine with oxaliplatin or 5-fluorouracil with folinic acid and oxaliplatin.

For breast cancer, chemotherapy options include eribulin, capecitabine, or paclitaxel.

4 monitoring and evaluation

Throughout the trial, participants are monitored for any side effects or adverse reactions.

Regular assessments include laboratory tests and heart function evaluations.

5 follow-up and conclusion

The trial is expected to conclude by April 2027.

Participants will have follow-up visits to assess long-term effects and overall health outcomes.

Who Can Join the Study?

  • Participants must be 18 years or older at the time of signing the consent form.
  • Must have a solid tumor that has been confirmed through medical tests.
  • The disease must be locally advanced, meaning it has spread nearby, or it must have come back after treatment (relapsed/refractory), or it must be unresectable metastatic disease, meaning it has spread to other parts of the body and cannot be removed by surgery.
  • The disease must be HER2 positive, which is a specific type of cancer that has more HER2 proteins than normal.
  • Must have had prior treatment based on the specific part of the study and type of tumor (details are in the study protocol).
  • For certain parts of the study (Phase 1b arms), participants must have at least one measurable lesion (a tumor that can be measured) based on a specific guideline called RECIST v1.1 within 6 weeks before the first dose of the study drug.
  • Must have an ECOG performance status of 0-1, which means the participant is fully active or has some symptoms but can still do light work.
  • Must have a left ventricular ejection fraction (LVEF) of 50% or higher, which is a measure of how well the heart is pumping, checked by an echocardiogram (ECHO) or another test called MUGA if ECHO cannot be done, within 28 days before the first dose of the study drug.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the ones being studied, such as cancers that are not solid tumors, colorectal cancer, or breast cancer.
  • Patients who do not have advanced stage HER2 positive cancer. HER2 positive means that the cancer has a protein called HER2 on its surface, which can make the cancer grow faster.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to safely receive the study treatments due to other health conditions.
  • Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
University Hospital Maastricht Maastricht The Netherlands
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre hospitalier universitaire de Liege Liege Belgium
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital Quironsalud Barcelona Barcelona Spain
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Stichting Radboud University Medical Center Nijmegen The Netherlands
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Universita’ Di Pisa Pisa Italy
Gasthuiszusters Antwerpen Antwerp Belgium
Hospital Hm Nou Delfos Barcelona Spain
Institut de Cancérologie de l’Ouest Saint-Herblain France
Cbzbkysac Umrgshzqzjstsg Sbvmhylah Woluwe-Saint-Lambert Belgium
Isgagzrw Rrjtenub Dl Cevoaa Dz Mzbhxcquwqn Montpellier France
Avakftl Uvy Isoht Do Rvxpph Elwpqi Reggio Emilia Italy
Uryadunjuk Mmxmj Glcktzy Of Ccxkfrezo Catanzaro Italy
Hnukfwin Vtuc ddxkraro Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.09.2024
France France
Not recruiting
01.09.2024
Italy Italy
Not recruiting
01.09.2024
Spain Spain
Not recruiting
01.09.2024
The Netherlands The Netherlands
Not recruiting
01.09.2024

Trial locations

ELVN-002 is an investigational medication being studied for its potential to treat advanced stage HER2 positive solid tumors. In this trial, it is being tested in combination with other treatments to evaluate its safety and how well it is tolerated by patients. The goal is to find the best dose to use when combined with other therapies.

Trastuzumab is a medication used to treat certain types of cancer that are HER2 positive. It works by targeting and blocking the HER2 protein, which can help slow down or stop the growth of cancer cells. In this trial, trastuzumab is combined with ELVN-002 and other chemotherapy treatments to assess its effectiveness in treating advanced stage HER2 positive cancers.

CAPEOX is a chemotherapy regimen that includes capecitabine and oxaliplatin. It is used to treat colorectal cancer by interfering with the growth of cancer cells. In this study, CAPEOX is combined with ELVN-002 and trastuzumab to evaluate its safety and effectiveness in patients with advanced stage HER2 positive colorectal cancer.

mFOLFOX6 is another chemotherapy regimen that includes 5-fluorouracil, leucovorin, and oxaliplatin. It is used to treat colorectal cancer by targeting cancer cells and preventing them from growing. This trial combines mFOLFOX6 with ELVN-002 and trastuzumab to study its impact on advanced stage HER2 positive colorectal cancer.

Eribulin is a chemotherapy drug used to treat breast cancer. It works by stopping cancer cells from dividing and growing. In this trial, eribulin is combined with ELVN-002 and trastuzumab to explore its safety and effectiveness in patients with advanced stage HER2 positive breast cancer.

Capecitabine is a chemotherapy medication that is used to treat various types of cancer, including breast cancer. It is taken orally and works by interfering with the DNA of cancer cells, preventing them from growing. In this study, capecitabine is used alongside ELVN-002 and trastuzumab to assess its role in treating advanced stage HER2 positive breast cancer.

Paclitaxel is a chemotherapy drug used to treat breast cancer. It works by stopping cancer cells from dividing, which can help slow or stop the growth of the cancer. In this trial, paclitaxel is combined with ELVN-002 and trastuzumab to evaluate its safety and effectiveness in patients with advanced stage HER2 positive breast cancer.

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body and are classified based on the type of cells they originate from. These tumors can grow and spread to other parts of the body, a process known as metastasis. The progression of solid tumors depends on their location, size, and the specific type of cells involved. They can cause symptoms by pressing on nearby organs or tissues.

Colorectal Cancer – Colorectal cancer begins in the colon or rectum, parts of the digestive system. It often starts as small, benign clumps of cells called polyps, which can become cancerous over time. As the cancer progresses, it can invade the walls of the colon or rectum and spread to nearby lymph nodes or other organs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary based on factors like the cancer’s stage and location.

Breast Cancer – Breast cancer originates in the cells of the breast, often in the ducts or lobules. It can spread to nearby lymph nodes and other parts of the body. The disease progresses through stages, from localized tumors to more advanced stages where cancer cells have spread. Symptoms may include a lump in the breast, changes in breast shape, or skin changes. The rate of progression can vary depending on the type and characteristics of the cancer cells.

Trial ID:
2023-509716-29-00
Protocol code:
ELVN-002-003
NCT ID:
NCT06328738
Trial Phase:
Human Pharmacology (Phase I) – Other

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