Study on Finding the Right Dose of Zongertinib with Trastuzumab Deruxtecan or Trastuzumab Emtansine for Treating HER2+ Cancer That Has Spread

Sponsor: Boehringer Ingelheim

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06324357

Provider View

This clinical trial is testing a new treatment combination for adults with HER2+ cancer that has spread and cannot be removed by surgery. The study aims to find a suitable dose of the drug zongertinib when used with trastuzumab deruxtecan or trastuzumab emtansine, and to see if this combination can help shrink tumors.

Patient Parameters

Program Overview

This study is for adults with HER2+ cancer that has spread and cannot be removed by surgery. It aims to find the best dose of zongertinib that can be tolerated when combined with trastuzumab deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1). The study also wants to see if this combination can help shrink tumors. Zongertinib works by blocking HER2, which helps cancer cells grow. Participants will receive zongertinib with either T-DXd or T-DM1 in treatment cycles. The study has two parts: Part 1 tests increasing doses of zongertinib, and Part 2 randomly assigns participants to different dose groups. Regular visits to the study site are required to monitor health and tumor size using imaging tests like CT or MRI.

Eligibility Criteria

Inclusion Criteria

  • Signed informed consent form.
  • Age 18 or older.
  • Have HER2+ cancer that has spread, such as breast cancer or certain types of stomach or esophageal cancer.
  • Provide a tumor sample if possible.
  • Cancer must have progressed after previous treatments.
  • Recovered from previous treatment side effects to a mild level.
  • Have at least one measurable tumor.
  • Good overall health with an ECOG score of 0 or 1.

Exclusion Criteria

  • Have had another cancer in the past 2 years that needs treatment, except for certain skin or cervical cancers that have been effectively treated.
  • Have serious heart problems like uncontrolled high blood pressure or recent heart attack.
  • Have abnormal heart rhythms or conditions that affect heart rhythm.
  • Have a heart's pumping ability below 50%.
  • Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or within 7 months after treatment.

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