Evaluating the safety 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
This study is testing a new drug called IPH4502 to see if it's safe and effective for people with advanced solid tumors that express a specific protein.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Innate Pharma Industry-sponsored |
| Locations | 7 sites (Boston, Massachusetts and 6 other locations) |
| Trial ID | NCT06781983 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, open-label, multicenter Phase 1 study designed to assess the safety, tolerability, and preliminary efficacy of IPH4502 in patients with advanced solid tumors expressing Nectin-4. The study employs a dose escalation approach guided by a Bayesian optimal interval design, followed by dose optimization in selected indications. Participants will receive escalating doses of IPH4502, and the study aims to determine the recommended Phase 2 dose while monitoring pharmacokinetics and safety.
Who should consider this trial
Good fit: Ideal candidates include patients with unresectable, locally advanced or metastatic solid tumors that express Nectin-4 and have not benefited from prior systemic treatments.
Not a fit: Patients with known or suspected brain metastases or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have limited therapeutic options.
How similar studies have performed: While this approach is novel in targeting Nectin-4, similar studies have shown promise in evaluating new therapies for advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 6 other locations
- Massachusetts General Hospital - Boston — Boston, Massachusetts, United States (Recruiting)
- John Theurer Cancer Center — Hackensack, New Jersey, United States (Recruiting)
- Mount Sinai Tisch Cancer Center — New York, New York, United States (Recruiting)
- NEXT Oncology - Dallas — Dallas, Texas, United States (Recruiting)
- NEXT Oncology - Virginia — Fairfax, Virginia, United States (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Gustave Roussy Cancer Institute — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Innate Pharma
- Email: clinical.trials@innate-pharma.fr
- Phone: +33430303030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.