Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer

This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy (see inclusion criteria below). The study will comprise of 2 cohorts. Cohort A will include participants with hormone receptor positive/ human epidermal growth factor receptor 2 negative \[HR+/HER2-\] breast cancer, whereas Cohort B will include participants with triple-negative breast cancer (TNBC).

Trial Details

NCT ID
NCT06840483
Phase
PHASE2
Sponsor
BicycleTx Limited
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Zelenectide pevedotin (BT8009)
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Aurora, Colorado, United States|39.72943,-104.83192
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Baltimore, Maryland, United States|39.29038,-76.61219

Key Eligibility Criteria

  • Archival or fresh tumor tissue comprised of TNBC or HR+/HER2-negative invasive breast cancer available for NECTIN4 gene amplification testing.
  • Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay (CTA).
  • Measurable disease as defined by RECIST v1.1.
  • Life expectancy ≥ 12 weeks.

For full eligibility, visit ClinicalTrials.gov.

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