Study on Zelenectide Pevedotin for Advanced Breast Cancer

Sponsor: BicycleTx Limited

Sponsor score: 0

ClinicalTrials ID:NCT06840483

Provider View

This clinical trial is testing a new treatment, zelenectide pevedotin, for patients with advanced breast cancer that has returned, cannot be removed by surgery, or has spread to other parts of the body. The study includes two groups: one for patients with hormone receptor positive/HER2-negative breast cancer and another for those with triple-negative breast cancer.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well a new drug, zelenectide pevedotin, works and how safe it is for patients with advanced breast cancer. The study is open to patients worldwide and includes two groups: one for those with hormone receptor positive/HER2-negative breast cancer and another for those with triple-negative breast cancer. Participants must have a specific type of breast cancer that has returned, cannot be surgically removed, or has spread, and they must have already received some prior treatments.

Eligibility Criteria

Inclusion Criteria

  • Have hormone receptor positive/HER2-negative breast cancer that is resistant to hormone therapy and have received up to three previous treatments for advanced cancer.
  • For Cohort B: Have triple-negative breast cancer, including cases where a small percentage of cells show hormone receptors, and have received between one and three previous treatments for advanced cancer.

Exclusion Criteria

  • Have previously been treated with any drug similar to zelenectide pevedotin.
  • Have allergies to any ingredients in the study treatment.
  • Have been previously tested as HER2-positive.
  • Have active eye infections or ulcers.
  • Have untreated or active cancer spread to the brain.
  • Have uncontrolled diabetes or high blood pressure.
  • Have fluid buildup around the lungs, heart, or abdomen that needs frequent draining.
  • Have lung diseases requiring ongoing steroid treatment.
  • Need to take certain medications that affect how the body processes drugs.
  • Have received any cancer treatment within 28 days before starting the study treatment.

Locations

FACILITYZIPCITYSTATE
SCRI Oncology Partners37203NashvilleTennessee

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