Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
BicycleTx Limited
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤ 1.
You may not be if
Prior treatment with any antibody drug conjugate (ADC) 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 to 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 central nervous system (CNS) metastases.
Uncontrolled diabetes or hypertension.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently).
Active interstitial lung disease or pneumonitis requiring ongoing treatment with steroids (\>10mg/day of prednisone or equivalent) or other immunosuppressive medications.
Requirement, while on study, for treatment with strong inhibitors 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
