Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

Criteria the registry did not label

• Main Inclusion Criteria:
• Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4
• Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available.
• Measurable disease according to RECIST 1.1.
• Archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline.
• Adequate organ function and hematological function.
  • Main Exclusion Criteria:
• Known or suspected brain metastases.
• Participants with an active infection, Any other infection requiring systemic treatment or latent infection.
• Participants with clinically significant comorbidity(s).
• History of treatment for, or suspicion or confirmed interstitial lung disease (ILD) at baseline.
• Condition being treated with systemic corticosteroids or immunosuppressive therapy during IPH4502 treatment.
• Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the first dose of IPH4502.
• Clinically significant cardiovascular disease and/or cardiac repolarization abnormality.
• Participants with symptomatic heart failure, Acute coronary syndromes
• Participant is receiving or has received anticancer therapy prior to enrolment that may have impact on the assessment of IPH4502.
• Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6 months for coronary artery bypass surgery.
• Concomitant medications or vaccines : Live-attenuated vaccines ≤ 6 weeks prior to first dose of IPH4502; systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first dose of IPH4502; systemic use of moderate or strong CYP 3A4 inhibitors; systemic use of moderate or strong CYP 3A4 inducers.