Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

ID#: NCT06781983

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: January 24, 2025

End Date: April 01, 2029

Contact Information:
Innate Pharma
+33430303030
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.