NCT06781983

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_1

Timeline
35mo left

Started Jan 2025

Longer than P75 for phase_1

Geographic Reach
2 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jan 2025Apr 2029

First Submitted

Initial submission to the registry

January 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

January 24, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

January 7, 2026

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

January 8, 2025

Last Update Submit

January 5, 2026

Conditions

Advanced or Metastatic Solid Tumors

Keywords

ExatecanTopo-Isomerase I inhibitorSquamous cell carcinoma of the head and neckEsophageal squamous cell carcinomaTriple negative breast cancerNon-small cell lung cancerGastro-esophageal junction and gastric cancerColorectal carcinomaOvarian carcinomaProstate cancerCervical cancerMelanomaUrothelial carcinomaAntibody-drug conjugatesADC

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    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 Outcomes (6)

  • Maximum Observed Plasma Concentration (Cmax)

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

  • Area Under the Plasma Concentration (AUC)

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

  • Incidence of antidrug antibodies (ADA) against IPH4502

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

  • Objective Response Rate (ORR)

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

  • Duration Of Response (DoR)

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

  • +1 more secondary outcomes

Study Arms (1)

IPH4502 Monotherapy

EXPERIMENTAL
Drug: IPH4502

Interventions

IPH4502DRUG

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

IPH4502 Monotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Massachusetts General Hospital - Boston

Boston, Massachusetts, 02114, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Mount Sinai Tisch Cancer Center

New York, New York, 10029, United States

RECRUITING

NEXT Oncology - Dallas

Dallas, Texas, 75039, United States

RECRUITING

NEXT Oncology - Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

Gustave Roussy Cancer Institute

Villejuif, 94805, France

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and NeckEsophageal Squamous Cell CarcinomaTriple Negative Breast NeoplasmsCarcinoma, Non-Small-Cell LungStomach NeoplasmsColorectal NeoplasmsOvarian NeoplasmsProstatic NeoplasmsUterine Cervical NeoplasmsMelanomaCarcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin Neoplasms

Central Study Contacts

Innate Pharma

CONTACT

+33430303030clinical.trials@innate-pharma.fr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 17, 2025

Study Start

January 24, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

January 7, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)US(5)