RECRUITING

Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

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Conditions

Advanced or Metastatic Solid TumorsExatecanTopo-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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors

Quick Facts

Study Start:2025-01-30
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06781983

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4
  2. * Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available.
  3. * Measurable disease according to RECIST 1.1.
  4. * 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.
  5. * Adequate organ function and hematological function.
  1. * Known or suspected brain metastases.
  2. * Participants with an active infection, Any other infection requiring systemic treatment or latent infection.
  3. * Participants with clinically significant comorbidity(s).
  4. * History of treatment for, or suspicion or confirmed interstitial lung disease (ILD) at baseline.
  5. * Condition being treated with systemic corticosteroids or immunosuppressive therapy during IPH4502 treatment.
  6. * Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the first dose of IPH4502.
  7. * Clinically significant cardiovascular disease and/or cardiac repolarization abnormality.
  8. * Participants with symptomatic heart failure, Acute coronary syndromes
  9. * Participant is receiving or has received anticancer therapy prior to enrolment that may have impact on the assessment of IPH4502.
  10. * Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6 months for coronary artery bypass surgery.
  11. * 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.

Contacts and Locations

Study Contact

Innate Pharma
CONTACT
+33430303030
clinical.trials@innate-pharma.fr

Study Locations (Sites)

NEXT Oncology - Dallas
Dallas, Texas, 75039
United States
NEXT Oncology - Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: 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 Registration Dates

Study Start Date2025-01-30
Study Completion Date2029-04

Study Record Updates

Study Start Date2025-01-30
Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

  • Exatecan
  • Topo-Isomerase I inhibitor
  • Squamous cell carcinoma of the head and neck
  • Esophageal squamous cell carcinoma
  • Triple negative breast cancer
  • Non-small cell lung cancer
  • Gastro-esophageal junction and gastric cancer
  • Colorectal carcinoma
  • Ovarian carcinoma
  • Prostate cancer
  • Cervical cancer
  • Melanoma
  • Urothelial carcinoma
  • Antibody-drug conjugates
  • ADC

Additional Relevant MeSH Terms

  • Advanced or Metastatic Solid Tumors