A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (SYNERGY-001)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 241
- 试验地点
- 47
- 主要终点
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
研究概览
简要总结
This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD-101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
This study will be conducted in 2 phases. Phase 1 evaluates SD-101 given in combination with pembrolizumab in melanoma populations (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease) in up to 4 Dose Escalation cohorts to identify a recommended Phase 2 dose (RP2D) to be evaluated in up to 4 Dose Expansion cohorts in Phase 2. Phase 2 also includes up to 4 Dose Expansion cohorts of patients with HNSCC (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease).
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
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation Phase 1b
Determine the maximum tolerated dose (MTD) of escalating doses of SD-101(1) administered in combination with pembrolizumab in patients with melanoma (anti-PD-1/L1 therapy naïve and experienced patients with progressive disease).
干预措施: SD-101(1) (Drug)
Dose Escalation Phase 1b
Determine the maximum tolerated dose (MTD) of escalating doses of SD-101(1) administered in combination with pembrolizumab in patients with melanoma (anti-PD-1/L1 therapy naïve and experienced patients with progressive disease).
干预措施: Pembrolizumab (Biological)
Dose Expansion Phase 2 (Cohort 1)
Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.
干预措施: SD-101(2) (Drug)
Dose Expansion Phase 2 (Cohort 1)
Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.
干预措施: Pembrolizumab (Biological)
Dose Expansion Phase 2 (Cohort 2)
Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent or metastatic melanoma.
干预措施: SD-101(2) (Drug)
Dose Expansion Phase 2 (Cohort 2)
Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent or metastatic melanoma.
干预措施: Pembrolizumab (Biological)
Dose Expansion Phase 2 (Cohort 3)
Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.
干预措施: SD-101(2) (Drug)
Dose Expansion Phase 2 (Cohort 3)
Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.
干预措施: Pembrolizumab (Biological)
Dose Expansion Phase 2 (Cohort 4)
Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent head and neck squamous cell carcinoma.
干预措施: SD-101(2) (Drug)
Dose Expansion Phase 2 (Cohort 4)
Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent head and neck squamous cell carcinoma.
干预措施: Pembrolizumab (Biological)
Dose Expansion Phase 2 (Cohort 5)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.
干预措施: SD-101(3) (Biological)
Dose Expansion Phase 2 (Cohort 5)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.
干预措施: Pembrolizumab (Biological)
Dose Expansion Phase 2 (Cohort 6)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.
干预措施: SD-101(3) (Biological)
Dose Expansion Phase 2 (Cohort 6)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.
干预措施: Pembrolizumab (Biological)
Dose Expansion Phase 2 (Cohort 7)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent head and neck squamous cell carcinoma.
干预措施: SD-101(3) (Biological)
Dose Expansion Phase 2 (Cohort 7)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent head and neck squamous cell carcinoma.
干预措施: Pembrolizumab (Biological)
Dose Expansion Phase 2 (Cohort 8)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent or metastatic melanoma.
干预措施: SD-101(3) (Biological)
Dose Expansion Phase 2 (Cohort 8)
Determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent or metastatic melanoma.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group
时间窗: Day 1 through Day 743
Overall response rate (ORR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS).
Phase 1 Dose Escalation Only - Number of Participants With DLTs
时间窗: Day 1 through Day 29
Dose-limiting toxicities (DLTs) are defined per protocol as specific AEs occurring from the time of the first injection (Day 1) through Day 29.
次要结局
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group(Day 1 through Day 743)
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group(Day 1 through Day 743)
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group(Day 1 through Day 743)
- Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group(Day 1 through Day 743)