Study on T-DXd for Treating Solid Tumors with HER2 Mutations

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT04639219

Provider View

This clinical trial is testing the effectiveness and safety of T-DXd for patients with solid tumors that have specific HER2 mutations. It is aimed at those whose cancer has spread or cannot be removed by surgery and who have limited treatment options.

Patient Parameters

Program Overview

This study is exploring the use of T-DXd, a medication for treating solid tumors that have specific HER2 mutations. It is open to patients whose cancer has spread or cannot be surgically removed and who have either not responded to previous treatments or have no other satisfactory treatment options. The study will assess the effectiveness and safety of T-DXd in these patients. HER2 mutations will be identified using specific genetic tests, and patients who have previously received HER2-targeted therapy can participate.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older, with some local age restrictions.
  • Have solid tumors that cannot be removed by surgery or have spread, with specific HER2 mutations confirmed by genetic tests.
  • Have tried previous treatments without success or have no other good treatment options.
  • Previous HER2-targeted therapy is allowed.
  • Must provide a tumor sample for further testing.
  • Heart function must be at least 50%.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must have measurable disease as determined by the study doctor.

Exclusion Criteria

  • Have HER2 overexpressing breast, gastric, or gastroesophageal cancer.
  • Have HER2 mutant non-small cell lung cancer (NSCLC).
  • Have had a heart attack or serious heart problems in the last 6 months.
  • Have a history of lung inflammation or current lung disease that cannot be ruled out.
  • Have a prolonged QT interval on an ECG test.
  • Have severe lung-related illnesses.
  • Have a history of immune system deficiencies or active infections like HIV, hepatitis B, or hepatitis C.
  • Have uncontrolled infections needing IV treatment.
  • Have fluid buildup around the lungs, heart, or abdomen that needs draining.
  • Have spinal cord compression or active cancer spread to the brain.

Locations

FACILITYZIPCITYSTATE
Research Site95403Santa RosaCalifornia
Research Site47303MuncieIndiana
Research Site02115BostonMassachusetts
Research Site02215BostonMassachusetts
Research Site07748MiddletownNew Jersey
Research Site11725CommackNew York
Research Site10604HarrisonNew York
Research Site10021New YorkNew York
Research Site77030HoustonTexas
Research Site22031FairfaxVirginia

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