Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

January 5, 2026 updated by: Innate Pharma

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

145

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon, France, 69008
        • Recruiting
        • Centre Leon Berard
        • Principal Investigator:
          • Armelle Vinceneux, MD
      • Villejuif, France, 94805
        • Recruiting
        • Gustave Roussy Cancer Institute
        • Principal Investigator:
          • Yohann Loriot, MD
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital - Boston
        • Principal Investigator:
          • Leon Pappas, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center
        • Principal Investigator:
          • Martin Gutierrez, MD
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Tisch Cancer Center
        • Principal Investigator:
          • Thomas Marron, MD
    • Texas
      • Dallas, Texas, United States, 75039
        • Recruiting
        • NEXT Oncology - Dallas
        • Contact:
          • Shiraj Sen, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Next Oncology - Virginia
        • Contact:
          • Alex Spira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPH4502 Monotherapy
Drug: IPH4502
Part 1 (dose escalation) and Part 2 (dose optimization)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: From time of first dose through treatment period, including the follow-up: up to 24 months
To evaluate the incidence of AEs, SAEs, TEAEs, and DLTs.
From time of first dose through treatment period, including the follow-up: up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
To characterize and evaluate the pharmacokinetic profile of IPH4502.
From time of informed consent through treatment period, including the follow-up: up to 24 months
Area Under the Plasma Concentration (AUC)
Time Frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
To characterize and evaluate the pharmacokinetic profile of IPH4502.
From time of informed consent through treatment period, including the follow-up: up to 24 months
Incidence of antidrug antibodies (ADA) against IPH4502
Time Frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
To evaluate the immunogenicity of IPH4502.
From time of informed consent through treatment period, including the follow-up: up to 24 months
Objective Response Rate (ORR)
Time Frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
To investigate any preliminary antitumor activity of IPH4502.
From time of informed consent through treatment period, including the follow-up: up to 24 months
Duration Of Response (DoR)
Time Frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
To investigate any preliminary antitumor activity of IPH4502.
From time of informed consent through treatment period, including the follow-up: up to 24 months
Progression Free Survival (PFS)
Time Frame: From time of informed consent through treatment period, including the follow-up: up to 24 months
To investigate any preliminary antitumor activity of IPH4502.
From time of informed consent through treatment period, including the follow-up: up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innate Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPH4502-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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