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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IPH4502 Monotherapy
Drug: IPH4502
Part 1 (dose escalation) and Part 2 (dose optimization)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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