Phase 2 Study of T-DXd for Treating Certain HER2-Positive Tumors

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04482309

Provider View

This clinical trial is testing the effectiveness and safety of a drug called trastuzumab deruxtecan (T-DXd) for treating various cancers that express the HER2 protein. The study includes different groups of patients with specific types of cancer to see how well the drug works.

Patient Parameters

Program Overview

This study is exploring the use of trastuzumab deruxtecan (T-DXd) to treat different types of cancers that have the HER2 protein. The trial is divided into two parts. Part 1 includes patients with cancers like bladder, biliary tract, cervical, endometrial, ovarian, pancreatic, and some rare tumors. Part 2 focuses on patients with any HER2-positive tumor, excluding breast, gastric, and colorectal cancers, and includes specific groups for endometrial, ovarian, and cervical cancers. The aim is to see if T-DXd can effectively treat these cancers and is safe for patients.

Eligibility Criteria

Inclusion Criteria

  • Have advanced cancer that cannot be removed by surgery or has spread, as shown by recent scans.
  • For Part 1, patients must have one of the following cancers:
    • Biliary tract cancer
    • Bladder cancer
    • Cervical cancer
    • Endometrial cancer
    • Ovarian cancer
    • Pancreatic cancer
    • Rare tumors that express HER2, excluding certain common cancers
  • For Part 2, patients must have:
    • Any advanced solid tumor with high HER2 expression, excluding certain common cancers
    • Endometrial, ovarian, or cervical cancer with lower HER2 expression
  • Must have tried other treatments without success or have no other good treatment options.
  • Previous treatment targeting HER2 is allowed.
  • HER2 levels must be confirmed using specific medical guidelines.
  • Must have measurable disease as determined by the study doctor.
  • Must have good organ function, including heart, kidney, and liver health.

Exclusion Criteria

  • History of lung inflammation that needed steroids or current lung issues that cannot be ruled out by scans.
  • Severe lung-related illnesses.
  • Uncontrolled infections needing IV antibiotics or other treatments.
  • Fluid buildup around the lungs, heart, or abdomen that needs draining.
  • Known genetic mutation of HER2 without HER2 protein in the tumor.
  • Primary diagnosis of certain common cancers for Part 1, and specific exclusions for Part 2.
  • Medical conditions that could interfere with participating in the study.

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