A Phase 1b/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR-255 Monotherapy or in Combination With Cetuximab as a Salvage Regimen for Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
研究概览
简要总结
This is a Phase 1b/2, open-label multicenter study evaluating NKTR-255 as a monotherapy and together with cetuximab in patients with head and neck squamous cell carcinoma (HNSCC) and colorectal carcinoma (CRC).
详细描述
NKTR-255 is a cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects.
In the dose escalation (Phase 1/b) phase patients with HNSCC or CRC will be treated with ascending doses of NKTR-255 in combination with cetuximab, until the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) is reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Histologically confirmed diagnosis of a locally advanced or metastatic HNSCC or CRC.
- •Life expectancy > 12 weeks as determined by the Investigator.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Measurable disease per RECIST 1.
- •Progression on any first or second line platinum-based chemotherapy and/or anti-PD-1 or programmed death-ligand 1 antibody.
- •Patients must have received or were intolerant to at least 2 prior cancer therapy regimens administered for metastatic disease.
排除标准
- •Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s)
- •Prior surgery or radiotherapy within 14 days of initiating study drug(s)
- •Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis; active infection requiring systemic therapy within 7 days prior to dosing
- •Patients who have been previously treated with IL-2 or IL-15
- •Known Grade 3 or 4 hypersensitivity reaction to cetuximab, history of allergy to red meat or tick bites, or history of positive test results for immunoglobulin E antibodies against cetuximab
- •Patients who have an active, known, or suspected autoimmune disease
- •NOTE: Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Dose Escalation of NKTR-255 with Cetuximab
Establish RP2D, of NKTR-255 with cetuximab.
干预措施: NKTR-255 (Drug)
Dose Escalation of NKTR-255 with Cetuximab
Establish RP2D, of NKTR-255 with cetuximab.
干预措施: Cetuximab (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
时间窗: 60 days after the last dose of study treatment, up to an average of 6 months.
Safety and tolerability of NKTR-255 in combination with cetuximab as evaluated by dose limiting toxicities, incidence of drug-related Adverse Events (AEs), SAEs, and AEs leading to discontinuation, deaths, and clinical laboratory abnormalities per CTCAE 5.0
The Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NKTR-255 in Combination With Cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
时间窗: Up to 21 days
To define the MTD and/or RP2D of NKTR-255 in combination with cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
次要结局
未报告次要终点