Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

Launched by INNATE PHARMA · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called IPH4502 for patients with advanced solid tumors, which are cancers that have progressed and cannot be removed by surgery. The main goal of this study is to find out how safe IPH4502 is, how well it is tolerated by patients, and whether it shows any early signs of effectiveness. The trial is currently recruiting participants who are 65 years or older and have tumors that express a specific protein known as Nectin-4. To be eligible, patients must have a confirmed diagnosis of their cancer, have received previous treatments without success, and have measurable disease according to specific guidelines.

Participants in this trial can expect to receive the IPH4502 treatment and will be monitored closely for any side effects or reactions. They will also need to provide recent tumor tissue samples and may undergo additional tests to ensure they are suitable for the study. It is important to note that certain health conditions, like active infections or significant heart issues, may exclude someone from participating. This trial represents an important step in finding new options for patients facing advanced cancers.

Gender

ALL

Eligibility criteria

• 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.