Informations générales (source: ClinicalTrials.gov)
A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors
Interventional
Phase 1
Innate Pharma (Voir sur ClinicalTrials)
janvier 2025
avril 2029
25 juillet 2025
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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; systemic use of moderate or
strong CYP 3A4 inhibitors; systemic use of moderate or strong CYP 3A4 inducers.