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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPH4502 Monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPH4502 | Drug | Part 1 (dose escalation) and Part 2 (dose optimization) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | To evaluate the incidence of AEs, SAEs, TEAEs, and DLTs. | From time of first dose through treatment period, including the follow-up: up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | To characterize and evaluate the pharmacokinetic profile of IPH4502. | From time of informed consent through treatment period, including the follow-up: up to 24 months |
| Area Under the Plasma Concentration (AUC) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Innate Pharma | Contact | +33430303030 | clinical.trials@innate-pharma.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital - Boston | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D064726 | Triple Negative Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D008545 | Melanoma |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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To characterize and evaluate the pharmacokinetic profile of IPH4502. |
| From time of informed consent through treatment period, including the follow-up: up to 24 months |
| Incidence of antidrug antibodies (ADA) against IPH4502 | To evaluate the immunogenicity of IPH4502. | From time of informed consent through treatment period, including the follow-up: up to 24 months |
| Objective Response Rate (ORR) | To investigate any preliminary antitumor activity of IPH4502. | From time of informed consent through treatment period, including the follow-up: up to 24 months |
| Duration Of Response (DoR) | To investigate any preliminary antitumor activity of IPH4502. | From time of informed consent through treatment period, including the follow-up: up to 24 months |
| Progression Free Survival (PFS) | To investigate any preliminary antitumor activity of IPH4502. | From time of informed consent through treatment period, including the follow-up: up to 24 months |
| John Theurer Cancer Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
|
| Mount Sinai Tisch Cancer Center | Recruiting | New York | New York | 10029 | United States |
|
| NEXT Oncology - Dallas | Recruiting | Dallas | Texas | 75039 | United States |
|
| NEXT Oncology - Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| Centre Léon Bérard | Recruiting | Lyon | 69008 | France |
|
| Gustave Roussy Cancer Institute | Recruiting | Villejuif | 94805 | France |
|
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |