Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 1INTERVENTIONAL

Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4

Who May Be Eligible (Plain English)

Main Who May Qualify: - diagnosed by tissue sample (biopsy-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. - your organs (liver, kidneys, etc.) are working well enough based on blood tests and hematological function. Main Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

IPH4502

Part 1 (dose escalation) and Part 2 (dose optimization)

Locations (7)

Massachusetts General Hospital - Boston
Boston, Massachusetts, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Mount Sinai Tisch Cancer Center
New York, New York, United States
NEXT Oncology - Dallas
Dallas, Texas, United States
NEXT Oncology - Virginia
Fairfax, Virginia, United States
Centre Léon Bérard
Lyon, France
Gustave Roussy Cancer Institute
Villejuif, France