RecruitingRecruiting
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
NCT06781983 · Innate Pharma
In plain English
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Official title
A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in Advanced Solid Tumors
About this study
This is a first-in-human, open-label, multicenter, single-arm Phase 1 study, with a part 1 dose escalation guided by a Bayesian optimal interval design with backfilling (BOIN-BF), followed by a part 2 dose optimization in up to 2 selected indications. This study is to measure the safety, tolerability, pharmacokinetics, and preliminary efficacy of escalating doses of IPH4502 in patients with advanced solid tumors that are known to express Nectin-4.
Eligibility 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.
Study design
Enrollment target: 145 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-01-24
Estimated completion: 2029-04
Last updated: 2026-01-07
Interventions
Drug: IPH4502
Primary outcomes
- • Safety and Tolerability (From time of first dose through treatment period, including the follow-up: up to 24 months)
Sponsor
Innate Pharma · industry
Contacts & investigators
ContactInnate Pharma · contact · clinical.trials@innate-pharma.fr · +33430303030
All locations (7)
Massachusetts General Hospital - BostonRecruiting
Boston, Massachusetts, United States
John Theurer Cancer CenterRecruiting
Hackensack, New Jersey, United States
Mount Sinai Tisch Cancer CenterRecruiting
New York, New York, United States
NEXT Oncology - DallasRecruiting
Dallas, Texas, United States
NEXT Oncology - VirginiaRecruiting
Fairfax, Virginia, United States
Centre Léon BérardRecruiting
Lyon, France
Gustave Roussy Cancer InstituteRecruiting
Villejuif, France