Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

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

Conditions

Advanced or Metastatic Solid Tumors

Study Overview

Study Details

Study overview

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

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

Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

Condition
Advanced or Metastatic Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Dallas

NEXT Oncology - Dallas, Dallas, Texas, United States, 75039

Fairfax

NEXT Oncology - Virginia, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Innate Pharma,

Study Record Dates

2029-04