Assessing Zelenectide Pevedotin for Advanced Breast Cancer
Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced Breast Cancer
PHASE2 · BicycleTx Limited · NCT06840483
This study is testing a new treatment called zelenectide pevedotin to see if it helps people with advanced breast cancer that has specific tumor features and hasn't responded to other therapies.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BicycleTx Limited (industry) |
| Drugs / interventions | prednisone |
| Locations | 5 sites (Saint Louis, Missouri and 4 other locations) |
| Trial ID | NCT06840483 on ClinicalTrials.gov |
What this trial studies
This global, multicenter, open-label study evaluates the efficacy and safety of zelenectide pevedotin in patients with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer. Participants are divided into two cohorts: one for hormone receptor positive/HER2-negative breast cancer and another for triple-negative breast cancer. The study aims to determine how well this treatment works in patients who have previously undergone therapy. It includes specific eligibility criteria related to tumor characteristics and prior treatments.
Who should consider this trial
Good fit: Ideal candidates include individuals with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received prior therapy.
Not a fit: Patients without NECTIN4 gene amplification or those who have not received prior systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer who have limited treatment alternatives.
How similar studies have performed: Other studies targeting NECTIN4 in breast cancer have shown promise, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Archival or fresh tumor tissue comprised of recurrent unresectable or metastatic TNBC or HR+/HER2-negative breast cancer available for NECTIN4 gene amplification testing. * Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay. * Measurable disease as defined by RECIST v1.1. * Life expectancy ≥ 12 weeks. * Eastern Cooperative Oncology Group Performance Status of ≤ 2. * Cohort A Specific Inclusion Criteria: Histologically or cytologically confirmed HR+/HER2-negative endocrine resistant/refractory breast cancer according to ASCO-CAP guidelines and received up to 3 prior lines of non-endocrine therapy for advanced disease. * Cohort B Specific Inclusion Criteria: Histologically or cytologically confirmed TNBC, including ER-low positive breast cancers (1-10% of cells expressing hormonal receptors by IHC), according to ASCO-CAP guidelines and have received at least 1 but no more than 3 prior lines of systemic therapy for advanced disease. Exclusion Criteria * Prior treatment with any antibody drug conjugate containing an Monomethyl Auristatin E (MMAE) (vedotin) payload or other MMAE-based therapy. * Known hypersensitivity or allergy to any of the ingredients of any of the study interventions or MMAE. * Previously tested HER2-positive (IHC 3+ or ISH+) on prior pathology testing (per ASCO-CAP guidelines). * Active keratitis or corneal ulcerations. * Active or untreated CNS metastases. * Uncontrolled diabetes or hypertension. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent draining procedures (monthly or more frequently). * Active interstitial lung disease or penumonitis requiring ongoing treatment with steriods (\>10mg/day of prednisone or equivalent) or other immunosupressive medications. * Requirement, while on study, for treatment with strong inhiitors or strong inducers of human cytochrome P450 3A (CYP3A) or inhibitors of P-glycoprotein (P-gp) including herbal- or food-based inhibitors. * Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment Note: Additional protocol defined Inclusion/Exclusion criteria apply
Where this trial is running
Saint Louis, Missouri and 4 other locations
- Siteman Cancer Center — Saint Louis, Missouri, United States (RECRUITING)
- Compass Oncology - Rose Quarter Cancer Center — Portland, Oregon, United States (RECRUITING)
- SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
- Texas Oncology San Antonio — San Antonio, Texas, United States (RECRUITING)
- Virginia Oncology Associates — Norfolk, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: BicycleTx Limited
- Email: clinicalstudies@bicycletx.com
- Phone: 617-945-8155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, NECTIN4, Zelenectide pevedotin, HR+/HER2-negative, TNBC, Chemotherapy