RecruitingPhase 1NCT06781983

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


Sponsor

Innate Pharma

Enrollment

145 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria11

  • 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.

Interventions

DRUGIPH4502

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


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

View Full Details on ClinicalTrials.gov

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NCT06781983


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