Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

Clinicaltrials.gov ID: NCT06781983
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 105

Conditions

Advanced or Metastatic Solid Tumors

Drugs

IPH4502

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.

Locations

2 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Shiraj Sen, MD

Status

  • RECRUITING

Contact Person

  • Alexa Spira, MD

Eligibility Criteria

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

IPH4502 Monotherapy

  • DRUG:

    IPH4502

    Description:

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

Outcome Measures

Primary Outcome Measures

Safety and Tolerability

Time Frame: From time of first dose through treatment period, including the follow-up: up to 24 months

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Time Frame: 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

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

Objective Response Rate (ORR)

Time Frame: 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

Progression Free Survival (PFS)

Time Frame: From time of informed consent through treatment period, including the follow-up: up to 24 months

Timeline

  • Last Updated
    March 4, 2025
  • Start Date
    January 17, 2025
  • Today
    May 9, 2025
  • Completion Date ( Estimated )
    April 1, 2029

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