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Search / Trial NCT05359692

INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Launched by INCYTE BIOSCIENCES INTERNATIONAL SÀRL · May 3, 2022

Trial Information

Current as of June 18, 2025

Withdrawn

Keywords

Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma Of Head And Neck Anti Pd (L)1 Therapy Hnscc Scchn

ClinConnect Summary

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab in participants with GITR expression in recurrent or metastatic HNSCC who have progressed on or after prior systemic therapy including anti-PD-(L)1 therapy. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2)

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx), that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy). Participants with squamous cell carcinomas of the nasopharynx, salivary gland, or nonsquamous cell histology are excluded.
  • Documented progression on or after PD-(L)1 inhibitor alone or in combination with platinum-based chemotherapy for recurrent or metastatic HNSCC. Exception: Treatment Group B (Part 2, expansion): PD-(L)1-naïve.
  • ECOG performance status of 0 to 1.
  • Measurable disease based on RECIST v1.1.
  • Mandatory pre-treatment and on-treatment tumor biopsies.
  • GITR-positive tumor confirmed by central laboratory before study treatment start.
  • Willingness to avoid pregnancy or fathering children.
  • Exclusion Criteria:
  • Have received chemotherapy, targeted small molecule therapy or curative radiation within 21 days of first dose of study drug; prior mAB for anticancer therapy other within 28 days of first dose of study drug; or investigational study drugs or devices within 28 days or five half-lives prior to enrollment unless approved by medical monitor.
  • Prior treatment with any TNF Super Family agonist therapy.
  • Have not recovered to ≤ Grade 1 from toxic effects of prior therapy.
  • Laboratory and medical history parameters not within the Protocol-defined range before the first administration of study treatment.
  • Known active HBV or HCV, or Known to be seropositive for HIV.
  • Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
  • Have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
  • Known active infections requiring systemic treatment.

About Incyte Biosciences International Sàrl

Incyte Biosciences International Sàrl is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for patients with serious diseases, particularly in oncology and hematology. With a strong focus on precision medicine, Incyte leverages cutting-edge research and advanced technologies to address unmet medical needs. The company is committed to advancing clinical trials that evaluate novel treatments, fostering collaboration with healthcare professionals and organizations to enhance patient outcomes and drive scientific progress in the field.

Locations

Chicago, Illinois, United States

Boston, Massachusetts, United States

Pittsburgh, Pennsylvania, United States

Palo Alto, California, United States

New York, New York, United States

Houston, Texas, United States

Westwood, Kansas, United States

Louisville, Kentucky, United States

Detroit, Michigan, United States

Salt Lake City, Utah, United States

Baltimore, Maryland, United States

Hackensack, New Jersey, United States

Cincinnati, Ohio, United States

La Jolla, California, United States

Portland, Oregon, United States

Birmingham, Alabama, United States

New York, New York, United States

Richmond, Virginia, United States

Lakewood, California, United States

Whittier, California, United States

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Nawel Bourayou, MD

Study Director

Incyte Corporation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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