Clinical trial NCT06781983: Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced or Metastatic Solid Tumors
Keywords: Exatecan
Topo-Isomerase I inhibitor
Squamous cell carcinoma of the head and neck
Esophageal squamous cell carcinoma
Triple negative breast cancer
Non-small cell lung cancer
Gastro-esophageal junction and gastric cancer
Colorectal carcinoma
Ovarian carcinoma
Prostate cancer
Cervical cancer
Melanoma
Urothelial carcinoma
Antibody-drug conjugates
ADC
Lead sponsor: Innate Pharma
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed description: 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.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: From time of first dose through treatment period, including the follow-up: up to 24 months
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: From time of informed consent through treatment period, including the follow-up: up to 24 months
measure: Area Under the Plasma Concentration (AUC)
timeFrame: From time of informed consent through treatment period, including the follow-up: up to 24 months
measure: Incidence of antidrug antibodies (ADA) against IPH4502
timeFrame: From time of informed consent through treatment period, including the follow-up: up to 24 months
measure: Objective Response Rate (ORR)
timeFrame: From time of informed consent through treatment period, including the follow-up: up to 24 months
measure: Duration Of Response (DoR)
timeFrame: From time of informed consent through treatment period, including the follow-up: up to 24 months
measure: Progression Free Survival (PFS)
timeFrame: From time of informed consent through treatment period, including the follow-up: up to 24 months
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Tisch Cancer Center
state: New York
city: Dallas
country: United States
facility: NEXT Oncology - Dallas
state: Texas
city: Fairfax
country: United States
facility: NEXT Oncology - Virginia
state: Virginia
city: Villejuif
country: France
facility: Gustave Roussy Cancer Institute
Study officials:
References: