A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 63
- 试验地点
- 153
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathological diagnosis of cSCC.
- •Previously untreated or recurrent locally advanced (without nodal metastases) or metastatic (distant or regional metastasis) cSCC not amenable to curative surgery and/or radiotherapy.
- •Measurable disease based on either radiographic imaging per RECIST 1.1 or WHO criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Life expectancy > 3 months.
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Known history of an additional malignancy.
- •Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
- •Toxicity from prior therapy that has not recovered.
- •Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
- •Received thoracic radiation within 6 months of the first dose of study treatment.
- •Participation in another interventional clinical study while receiving INCB
- •Impaired cardiac function or clinically significant cardiac disease.
- •History or evidence of interstitial lung disease including noninfectious pneumonitis.
- •Presence of gastrointestinal conditions that may affect drug absorption.
- •Any autoimmune disease requiring systemic treatment in the past 5 years.
- •Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
- •Active infection requiring systemic therapy.
- •History of organ transplantation, including allogeneic stem cell transplantation.
- •Receipt of systemic antibiotics within 28 days of first dose of study treatment.
- •Probiotic usage is prohibited during screening and throughout the study treatment period.
- •Received a live vaccine within 28 days of the planned start of study drug.
- •Laboratory values outside the Protocol-defined ranges.
- •Inadequate organ function.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Part 1: INCB099280 Dose 3
Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.
干预措施: INCB099280 (Drug)
Part 2: INCB099280 Dose selected from Part 1
Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.
干预措施: INCB099280 (Drug)
Part 1: INCB099280 Dose 1
Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
干预措施: INCB099280 (Drug)
Part 1: INCB099280 Dose 2
Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
干预措施: INCB099280 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to 2 years
Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by the blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or composite criteria for metastatic cSCC and per World Health Organization (WHO) criteria for locally advanced cSCC.
Number of participants with TEAEs leading to dose modification or discontinuation
时间窗: Up to 2 years
Number of participants with TEAEs leading to dose modification or discontinuation.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 2 years 3 months
Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurs first.
次要结局
- Progression-free survival (PFS)(Up to 2 years)
- INCB099280 pharmacokinetic (PK) in Plasma(Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days))
- Disease Control Rate (DCR)(Up to 2 years)
- Duration Of Response (DOR)(Up to 2 years)
- Time to Response (TTR)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)