Active, not recruiting
Phase 1
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
Condition(s) studied
Advanced or Metastatic Solid Tumors
Investigational drug(s) / intervention(s)
IPH4502
IPH4502: Part 1 (dose escalation) and Part 2 (dose optimization)
Study summary
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
Eligibility
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.
Primary outcome measure(s)
- Safety and Tolerability — From time of first dose through treatment period, including the follow-up: up to 24 months
To evaluate the incidence of AEs, SAEs, TEAEs, and DLTs.
Trial sites (7)
| Facility | City | Region | Status |
| Massachusetts General Hospital - Boston |
Boston |
Massachusetts |
|
| John Theurer Cancer Center |
Hackensack |
New Jersey |
|
| Mount Sinai Tisch Cancer Center |
New York |
New York |
|
| NEXT Oncology - Dallas |
Dallas |
Texas |
|
| NEXT Oncology - Virginia |
Fairfax |
Virginia |
|
| Centre Léon Bérard |
Lyon |
France |
|
| Gustave Roussy Cancer Institute |
Villejuif |
France |
|
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