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Active, Not Recruiting

NCT Number: NCT06781983

Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Advanced or Metastatic Solid Tumors Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Transitional Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Léon Bérard, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IPH4502

Drug

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

Primary outcomes

  1. Safety and Tolerability

    Time frame: 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.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months

    To characterize and evaluate the pharmacokinetic profile of IPH4502.

  2. Area Under the Plasma Concentration (AUC)

    Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months

    To characterize and evaluate the pharmacokinetic profile of IPH4502.

  3. Incidence of antidrug antibodies (ADA) against IPH4502

    Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months

    To evaluate the immunogenicity of IPH4502.

  4. Objective Response Rate (ORR)

    Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months

    To investigate any preliminary antitumor activity of IPH4502.

  5. Duration Of Response (DoR)

    Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months

    To investigate any preliminary antitumor activity of IPH4502.

  6. Progression Free Survival (PFS)

    Time frame: From time of informed consent through treatment period, including the follow-up: up to 24 months

    To investigate any preliminary antitumor activity of IPH4502.

Sponsors and collaborators

Lead sponsor

Innate Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 17, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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