Phase
Condition
Neoplasms
Treatment
IPH4502
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Main Inclusion Criteria:
Histologically confirmed, unresectable, locally advanced or metastatic solid tumorsthat are known to express Nectin-4
Prior systemic treatment for locally advanced or metastatic disease, yet no therapywith 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 lastanticancer therapy prior to the study or agree to undergo a tumor biopsy atbaseline.
Adequate organ function and hematological function.
Exclusion
Main Exclusion Criteria:
Known or suspected brain metastases.
Participants with an active infection, Any other infection requiring systemictreatment 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 therapyduring IPH4502 treatment.
Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the firstdose of IPH4502.
Clinically significant cardiovascular disease and/or cardiac repolarizationabnormality.
Participants with symptomatic heart failure, Acute coronary syndromes
Participant is receiving or has received anticancer therapy prior to enrolment thatmay have impact on the assessment of IPH4502.
Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6months for coronary artery bypass surgery.
Concomitant medications or vaccines : Live-attenuated vaccines ≤ 6 weeks prior tofirst dose of IPH4502; systemic corticosteroids or other immunosuppressive agentswithin 14 days prior to the first dose of IPH4502; systemic use of moderate orstrong CYP 3A4 inhibitors; systemic use of moderate or strong CYP 3A4 inducers.
Study Design
Study Description
Connect with a study center
Gustave Roussy Cancer Institute
Villejuif, 94805
FranceActive - Recruiting
John Theurer Cancer Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Mount Sinai Tisch Cancer Center
New York, New York 10029
United StatesActive - Recruiting
NEXT Oncology - Dallas
Dallas, Texas 75039
United StatesActive - Recruiting
NEXT Oncology - Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
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