Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

5 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • 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.

What is already known about the treatment

  • ELVN-002

    This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating advanced stage HER2-positive solid tumors, including colorectal and breast cancer. It is not yet approved for general medical use, as it is still in the early phases of clinical research. ELVN-002 is being tested in combination with trastuzumab, and sometimes with chemotherapy, to determine the best dosage and to evaluate its potential benefits. The drug works by targeting specific proteins on cancer cells, aiming to inhibit their growth and spread. It is classified as an investigational anti-cancer agent.

  • Trastuzumab

    This medication is administered intravenously and is widely used in the treatment of HER2-positive breast and colorectal cancers. It is well-established in medical literature and is approved for use in various cancer therapies. Trastuzumab works by binding to the HER2 protein on cancer cells, blocking their growth and signaling the immune system to destroy them. It is classified as a monoclonal antibody and is often used in combination with other cancer treatments to enhance effectiveness.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509716-29-00Protocol codeELVN-002-003Estimated enrolment275 patientsSponsorEnliven Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.