NCT06781983 · Innate Pharma
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
What this study is about
This is a first-in-human, where both patients and doctors know the treatment given, conducted at multiple hospitals, Phase 1 study to evaluate the safety, tolerability and preliminary effectiveness of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4
View original scientific 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
- Hackensack, New Jersey
- New York, New York
- Dallas, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations