Duravelo-3
Research type
Research Study
Full title
Phase 2 Study of Zelenectide Pevedotin in Participants with NECTIN4 Amplified Advanced Breast Cancer
IRAS ID
1011481
Contact name
Jonathan Kuhl
Contact email
Sponsor organisation
BicycleTx Limited
Clinicaltrials.gov Identifier
Research summary
Patients who develop advanced or metastatic breast cancer are unlikely to be cured, despite advances in therapy, median survival is now approximately 3 years. There remains an unmet need for new therapies for these patients. This Phase 2 study will evaluate the safety and effectiveness of the study drug, named zelenectide pevedotin (BT8009), in eligible participants. Eligible participants must have, among others, a so called NECTIN4 gene amplification, as the study drug recognises and binds to the protein coded by this gene. This study will have 2 cohorts with up to 33 participants in each cohort (66 participants overall). Cohort A will consist of patients with so called HR+/HER2-negative breast cancer while Cohort B will consist of patients with triple negative breast cancer (TNBC). The total time you could participate on the study may last to over 4 years. Participants in both cohorts will receive 6 mg/m2 zelenectide pevedotin monotherapy via intravenous infusion (IV) on day 1 and day 8 of each 21-day cycle, after their eligibility has been confirmed. The main objective of the study is to assess the clinical activity (efficacy) of zelenectide pevedotin in participants with NECTIN4 amplified tumours by the objective response rate (ORR), in other words, to see if and how well the study drug works. The safety and tolerability of zelenectide pevedotin will also be evaluated in addition to the clinical activity which will be assessed by additional response, survival, and disease control measurements. The objective response rate (ORR) will be measured by the percentage of participants who have a confirmed complete response (CR) or partial response (PR) to zelenectide pevedotin, once a patient starts zelenectide pevedotin to the time the therapy is no longer helping to treat the cancer, in other words when the disease gets worse, or until the study ends.
REC name
Wales REC 5
REC reference
25/WA/0091
Date of REC Opinion
22 Apr 2025
REC opinion
Further Information Favourable Opinion