Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

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Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06781983
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Innate Pharma
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced or Metastatic Solid Tumors

Additional Details

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.

Arms & Interventions

Arms

Experimental: IPH4502 Monotherapy

Interventions

Drug: - IPH4502

Part 1 (dose escalation) and Part 2 (dose optimization)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital - Boston, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Massachusetts General Hospital - Boston

Boston 4930956, Massachusetts 6254926, 02114

Site Contact

[email protected]

+33430303030

John Theurer Cancer Center, Hackensack 5098706, New Jersey 5101760

Status

Recruiting