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Tests treatment safety and results for Advanced or Metastatic Solid Tumors
Official title Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06781983
What this study is testing
What is IPH4502?
IPH4502 is an investigational medicine, being studied as a potential treatment for advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- 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...
- 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...
You likely can't join 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.
See the full eligibility criteria
- Main
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Dallas, Texas, United States
- Fairfax, Virginia, United States
- Lyon, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Hackensack, New Jersey, United States; New York, New York, United States; Dallas, Texas, United States; Fairfax, Virginia, United States; Lyon, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.