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RECRUITINGPHASE1

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

NCT06781983•Innate Pharma

View on ClinicalTrials.gov

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

Detailed Description

This is a first-in-human, open-label, multicenter, single-arm Phase 1 study, with a part 1 dose escalation guided by a Bayesian optimal interval design with backfilling (BOIN-BF), followed by a part 2 dose optimization in up to 2 selected indications. This study is to measure the safety, tolerability, pharmacokinetics, and preliminary efficacy of escalating doses of IPH4502 in patients with advanced solid tumors that are known to express Nectin-4.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.
+1 more criteria

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

Key Dates

Start Date

January 24, 2025

Primary Completion Date

April 1, 2028

Completion Date

April 1, 2029

Last Updated

January 7, 2026

Enrollment

145

ESTIMATED participants

Conditions

Advanced or Metastatic Solid Tumors

Interventions

IPH4502

DRUG

Contacts

Innate Pharma

CONTACT

+33430303030 clinical.trials@innate-pharma.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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