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Elvn-002-1

ELVN-002-1 is an investigational drug currently being studied in clinical trials for the treatment of HER2-positive solid tumors, including colorectal cancer and breast cancer. This article explores the ongoing research on ELVN-002-1 in combination with other cancer treatments, focusing on its potential benefits and safety profile for patients with advanced-stage cancers.

Table of Contents

What is ELVN-002-1?

ELVN-002-1 is a new investigational drug being developed by Enliven Therapeutics for the treatment of certain types of cancer[1]. It is currently being studied in a clinical trial to evaluate its safety and effectiveness when used in combination with other cancer treatments.

Target Conditions

ELVN-002-1 is specifically designed to target HER2-positive solid tumors. HER2 (Human Epidermal growth factor Receptor 2) is a protein that promotes the growth of cancer cells. The main conditions being studied in this trial include:

  • HER2-positive colorectal cancer (cancer of the colon or rectum)
  • HER2-positive breast cancer
  • Other HER2-positive solid tumors[1]

How ELVN-002-1 Works

While the exact mechanism of action is not fully described in the trial information, ELVN-002-1 is likely designed to target and inhibit the HER2 protein in cancer cells. By doing so, it may help to slow down or stop the growth of HER2-positive tumors[1].

Clinical Trial Overview

The clinical trial for ELVN-002-1 is a Phase 1a/1b study, which means it is an early-stage trial primarily focused on assessing the safety of the drug and determining the right dose to use in future studies. The trial is divided into several parts:

  1. Testing ELVN-002-1 in combination with trastuzumab (another HER2-targeted drug)
  2. Testing ELVN-002-1 with trastuzumab and various chemotherapy drugs
  3. Expanding the study to more patients with specific tumor types[1]

Potential Benefits

While it’s important to note that ELVN-002-1 is still in early stages of research, the study aims to evaluate several potential benefits:

  • Improved effectiveness against HER2-positive tumors when combined with existing treatments
  • Possible activity against brain metastases (cancer that has spread to the brain)
  • A new option for patients whose cancer has not responded to or has returned after previous treatments[1]

Eligibility Criteria

To participate in this study, patients must meet certain criteria, including:

  • Being 18 years or older
  • Having a confirmed HER2-positive solid tumor
  • Having advanced cancer that has spread or cannot be surgically removed
  • Having received certain prior treatments, depending on their cancer type
  • Being in relatively good overall health (able to perform daily activities)[1]

Safety Considerations

As with any new treatment, there may be risks and side effects associated with ELVN-002-1. The study is designed to carefully monitor patients for any adverse effects. Some key safety considerations include:

  • Patients with certain heart conditions may not be eligible
  • The study will monitor for effects on heart function and heart rhythm
  • Patients with active infections, liver disease, or certain other medical conditions may be excluded
  • The combination with other cancer drugs may have additional side effects[1]

It’s important for patients to discuss all potential risks and benefits with their healthcare provider and the study team before considering participation in this or any clinical trial.

Aspect Details
Drug Name ELVN-002-1
Cancer Types HER2-positive solid tumors, colorectal cancer, breast cancer
Administration Oral capsules, once or twice daily
Combination Therapies Trastuzumab, CAPEOX, mFOLFOX6, eribulin, capecitabine, paclitaxel
Study Phases Phase 1a and 1b
Primary Objectives Safety, tolerability, recommended dose determination
Secondary Objectives Efficacy assessment, pharmacokinetic profile, anti-tumor activity
Eligibility Adults (18+) with advanced HER2-positive solid tumors
Key Exclusions Severe cardiac issues, active infections, brain metastases requiring immediate therapy

FAQ

  • What is ELVN-002-1? ELVN-002-1 is an investigational drug being studied for the treatment of HER2-positive solid tumors, including colorectal cancer and breast cancer. It is being tested in combination with other cancer treatments like trastuzumab and chemotherapy.
  • What types of cancer is ELVN-002-1 being studied for? ELVN-002-1 is being studied for HER2-positive solid tumors, with a focus on colorectal cancer and breast cancer. It may also be investigated for other HER2-positive solid tumors in the future.
  • How is ELVN-002-1 administered? ELVN-002-1 is administered orally in the form of capsules. Depending on the study phase and treatment combination, it may be given once or twice daily.
  • What other treatments is ELVN-002-1 being combined with in the clinical trials? ELVN-002-1 is being studied in combination with trastuzumab (a targeted therapy for HER2-positive cancers) and various chemotherapy regimens, including CAPEOX, mFOLFOX6, eribulin, capecitabine, and paclitaxel.
  • What are the main goals of the clinical trials studying ELVN-002-1? The main goals of the clinical trials are to evaluate the safety and tolerability of ELVN-002-1 in combination with other treatments, determine the recommended dose, assess its effectiveness in treating HER2-positive solid tumors, and study its pharmacokinetic profile (how the drug moves through the body).

Ongoing Clinical Trials on Elvn-002-1

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy The Netherlands Spain

Glossary

  • HER2-positive: A type of cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.
  • Solid tumor: An abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancer) or malignant (cancer).
  • Trastuzumab: A targeted therapy drug used to treat HER2-positive breast cancer and some other HER2-positive cancers.
  • CAPEOX: A chemotherapy regimen that combines capecitabine and oxaliplatin.
  • mFOLFOX6: A chemotherapy regimen that combines oxaliplatin, leucovorin, and 5-fluorouracil.
  • Eribulin: A chemotherapy drug used to treat certain types of breast cancer.
  • Capecitabine: An oral chemotherapy drug used to treat various types of cancer, including breast and colorectal cancer.
  • Paclitaxel: A chemotherapy drug used to treat various types of cancer, including breast, ovarian, and lung cancer.
  • Pharmacokinetic (PK) profile: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Dose-limiting toxicity (DLT): Side effects of a drug that are severe enough to prevent an increase in dosage or require a reduction in dosage.

References

  1. http://clinicaltrials.eu/trial/study-of-elvn-002-with-trastuzumab-and-chemotherapy-for-patients-with-advanced-her2-solid-tumors-colorectal-cancer-and-breast-cancer/