Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

Last updated: May 1, 2025
Sponsor: Innate Pharma
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

IPH4502

Clinical Study ID

NCT06781983
IPH4502-101
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Main Inclusion Criteria:

  • Histologically confirmed, unresectable, locally advanced or metastatic solid tumorsthat are known to express Nectin-4

  • Prior systemic treatment for locally advanced or metastatic disease, yet no therapywith 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 lastanticancer therapy prior to the study or agree to undergo a tumor biopsy atbaseline.

  • Adequate organ function and hematological function.

Exclusion

Main Exclusion Criteria:

  • Known or suspected brain metastases.

  • Participants with an active infection, Any other infection requiring systemictreatment 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 therapyduring IPH4502 treatment.

  • Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the firstdose of IPH4502.

  • Clinically significant cardiovascular disease and/or cardiac repolarizationabnormality.

  • Participants with symptomatic heart failure, Acute coronary syndromes

  • Participant is receiving or has received anticancer therapy prior to enrolment thatmay have impact on the assessment of IPH4502.

  • Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6months for coronary artery bypass surgery.

  • Concomitant medications or vaccines : Live-attenuated vaccines ≤ 6 weeks prior tofirst dose of IPH4502; systemic corticosteroids or other immunosuppressive agentswithin 14 days prior to the first dose of IPH4502; systemic use of moderate orstrong CYP 3A4 inhibitors; systemic use of moderate or strong CYP 3A4 inducers.

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: IPH4502
Phase: 1
Study Start date:
January 24, 2025
Estimated Completion Date:
April 30, 2029

Study 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.

Connect with a study center

  • Gustave Roussy Cancer Institute

    Villejuif, 94805
    France

    Active - Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Mount Sinai Tisch Cancer Center

    New York, New York 10029
    United States

    Active - Recruiting

  • NEXT Oncology - Dallas

    Dallas, Texas 75039
    United States

    Active - Recruiting

  • NEXT Oncology - Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.