Study on Amivantamab for Treating Adenoid Cystic Carcinoma

Sponsor: Trisha Wise-Draper

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05074940

Provider View

This clinical trial is exploring whether the drug amivantamab can be effective in treating patients with adenoid cystic carcinoma, a rare type of cancer that often returns or spreads after initial treatment.

Patient Parameters

Program Overview

The study aims to find out if amivantamab, a medication that targets specific proteins involved in cancer growth, can help control adenoid cystic carcinoma (ACC). ACC is a rare cancer that usually affects the salivary glands and other glandular tissues. It grows slowly but often comes back or spreads to other parts of the body over time. Patients in this study will receive amivantamab weekly for the first cycle and then every two weeks. The dose may vary based on the patient's weight.

Description

Adenoid cystic carcinoma (ACC) is a rare cancer that typically affects the salivary glands but can also occur in other glandular tissues. It is known for being slow-growing but has a tendency to return or spread to other parts of the body over several years. Traditional treatments include surgery and radiation, but these may not always be effective in the long term.

This study is testing a drug called amivantamab, which is designed to block certain proteins (EGFR and MET) that help cancer cells grow. The hope is that amivantamab will be effective in treating ACC, especially in cases where the cancer has come back or spread.

Participants will receive amivantamab at a dose of 1050mg weekly for the first cycle and then every two weeks. For patients weighing 80kg or more, the dose will be 1400mg. The study will monitor how well the drug works and any side effects it may cause.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with adenoid cystic carcinoma, including non-salivary gland types.
  • Cancer has returned or spread and cannot be treated with surgery or other curative methods.
  • Evidence of cancer progression within 6 months before joining the study.
  • At least one tumor that can be measured by scans.
  • Age 18 or older.
  • Good overall health with a performance status that allows for daily activities.
  • Adequate organ and bone marrow function.
  • Treated brain metastases are allowed if stable for at least 4 weeks.
  • New or growing brain metastases are allowed if immediate treatment is not needed.
  • Other cancers are allowed if they do not interfere with the study treatment.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must use condoms during sexual activity and agree not to donate sperm during the study and for 6 months after.
  • Willingness to sign informed consent and follow study requirements.

Exclusion Criteria

  • Allergy or intolerance to amivantamab or its components.
  • Previous treatment with amivantamab.
  • Recent chemotherapy or immunotherapy within 4-6 weeks before the study.
  • Active hepatitis B or C infections unless controlled.
  • HIV positive with certain conditions affecting treatment.
  • Active cardiovascular disease or recent serious heart events.
  • Uncontrolled high blood pressure or heart failure.
  • Uncontrolled diabetes or active infections.
  • History of lung disease or pneumonitis.
  • Recent major surgery or planned surgery during the study.
  • Unresolved side effects from previous cancer treatments.
  • Participation in another clinical trial or investigational treatment.
  • Pregnant or breastfeeding women.
  • Any condition that makes participation unsafe or compliance unlikely.

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