Phase 2, Open-Label, Multicenter Study of INCAGN01876 in Combination With Immunotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 33
- 主要终点
- Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
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).
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open-label study
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Measurable disease based on RECIST v1.
- •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.
排除标准
- •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.
结局指标
主要结局
Part 1: Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Screening through 90 days after end of treatment, up to 24 months
A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
时间窗: Assessed every 8 weeks for 12 months, thereafter every 12 weeks up to the end of treatment, up to 24 months.
Defined as the percentage of participants having complete response (CR) or partial response (PR).
次要结局
- Progression-free survival (PFS) based on RECIST v1.1 and mRECIST(Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.)
- Part 2: Participants With Treatment-Emergent Adverse Events (TEAEs)(Screening through 90 days after end of treatment, up to 24 months)
- Duration of response (DOR) based on RECIST v1.1 and mRECIST(Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.)
- Disease control rate (DCR) based on RECIST v1.1 and mRECIST(Assessed every 8 weeks for 12 months, then every 12 weeks, up to 24 months.)