NCT05359692

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

Phase 2, Open-Label, Multicenter Study of INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Incyte Biosciences International Sàrl · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, tolerability, efficacy, PK and pharmacodynamics of INCAGN01876 when given in combination with retifanlimab. The study will consist of 2 parts: a safety lead-in part (Part 1) followed by a dose expansion part (Part 2).

Detailed description

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)

Conditions

• Metastatic Head and Neck Squamous Cell Carcinoma
• Advanced Malignancies
• Recurrent Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	INCAGN01876	INCAGN1876 will be adminstered via IV at at the protocol-defined dose and schedule according to cohort and treatment group enrollment.
BIOLOGICAL	retifanlimab	retifanlimab will be administered via IV Q4W

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-04-20
• Completion: 2025-01-11
• First posted: 2022-05-04
• Last updated: 2023-09-15

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study