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Clinical Trials in the USA / NCT06781983
Active, not recruiting Phase 1

Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

NCT06781983 · tracked via the Priya Life Science USA tracker
Sponsor
Innate Pharma
Phase
Phase 1
Started
2025-01-24
Last updated
2026-07-27

Condition(s) studied

Advanced or Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

IPH4502

IPH4502: Part 1 (dose escalation) and Part 2 (dose optimization)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (7)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06781983 on ClinicalTrials.gov ↗ ← All trials in the USA