A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory/Recurrent Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)
研究概览
简要总结
This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts:
- Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF).
- Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity.
- Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal/Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma
- •Age 18 years or older
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- •Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies
- •Availability of tumor tissue
- •Measurable disease per RECIST 1.1
- •Adequate organ function
- •Participants receiving anticoagulants must be on a stable dose
排除标准
- •Eye disorders
- •Untreated brain metastases
- •Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition
- •Previous solid organ or bone marrow transplantation
- •Concurrent participation in another therapeutic treatment trial
研究组 & 干预措施
Part 1A STRO-004 Monotherapy
干预措施: STRO-004 (Drug)
Part 1B STRO-004 Monotherapy
干预措施: STRO-004 (Drug)
Part 1C STRO-004 in Combination with Pembrolizumab
干预措施: Pembrolizumab (Drug)
Part 1C STRO-004 in Combination with Pembrolizumab
干预措施: STRO-004 (Drug)
结局指标
主要结局
Part 1A: Number of participants with Dose-limiting Toxicities (DLTs)
时间窗: Up to Day 21
Part 1A, 1B: Percentage of participants with Treatment-Emergent Adverse Events (TEAEs), with severity determined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale
时间窗: Up to 12 Months
Part 1A, 1B, 1C: Percentage of participants with clinical laboratory abnormalities, with severity determined according to the CTCAE v5.0 grading scale
时间窗: Up to 12 months
Part 1B: Objective Response Rate (ORR)
时间窗: Up to 12 months
Best response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Part 1B: Disease control rate (DCR)
时间窗: Up to 12 months
The proportion of participants with best response of CR, PR or Stable Disease (SD) per RECIST V1.1
Part 1B: Duration of Response (DOR)
时间窗: Up to 12 months
Time from first occurrence of objective response to the time of Progressive Disease (PD) according to RECIST v1.1 or death from any cause, whichever comes first
Part 1B: Progression-Free Survival (PFS)
时间窗: Up to 12 months
Time from first dose to the first occurrence of PD according to RECIST v1.1 or death from any cause, whichever comes first
Part 1B: 12-month survival rate
时间窗: 12 months
Percentage of participants alive 12 months after first dose of study treatment
Part 1C: Percentage of participants with TEAEs, with severity determined according to the CTCAE v5.0 grading scale
时间窗: Up to 12 months
次要结局
- Part 1A, 1B, 1C: Plasma concentrations of STRO-004 and its metabolites at specified timepoints(Up to 12 months)
- Part 1A, 1B, 1C: Immunogenicity(Up to 12 months)
- Part 1A: Objective Response Rate (ORR)(Best response of CR or PR per RECIST V1.1)
- Part 1A, 1C: Disease Control Rate (DCR)(Up to 12 months)
- Part 1A, 1C: Duration of Response (DOR)(Up to 12 months)
- Part 1A,1C: Progression-Free Survival (PFS)(Up to 12 months)
- Part 1A,1C: 12-month survival rate(12 months)