A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 111
- 试验地点
- 18
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
详细描述
The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Disease indication
- •Must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic option.
- •Non-small cell lung cancer (NSCLC)
- •HER2 negative breast cancer
- •Ovarian cancer
- •Cervical cancer
- •Endometrial cancer
- •Esophageal cancer
- •Gastric cancer and GEJ carcinoma
- •Colorectal cancer
- •Exocrine pancreatic adenocarcinoma
- •Appendiceal adenocarcinoma and pseudomyxoma peritonei of unknown origin
- •Participants enrolled in the following study parts should have an appropriate tumor site that satisfies the following criteria:
- •Site has tumor that is not a target lesion and has not been previously irradiated (unless progression has occurred since end of radiotherapy)
- •Site has tumor that is accessible for a minimally invasive biopsy that does not present a significant risk, AND
- •Participant must agree to a biopsy as follows
- •Disease-specific expansion cohorts: pre-treatment biopsy, unless medically infeasible following consultation with the medical monitor
- •Biology expansion cohort: pretreatment biopsy (required) and additional on-treatment biopsy during Cycle 1 (unless medically infeasible following consultation with the medical monitor)
- •Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) at baseline
- •An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Adequate renal, hepatic, and hematologic function
- •Exclusion Criteria
- •History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
- •Known active central nervous system metastases
- •Carcinomatous meningitis
- •Previous receipt of monomethylauristatin E (MMAE)-containing drugs
- •Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- •Any uncontrolled ≥ Grade 3 (per the NCI CTCAE, Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-STNV
- •There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
排除标准
- 未提供
研究组 & 干预措施
SGN-STNV
SGN-STNV monotherapy
干预措施: SGN-STNV (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
To be summarized using descriptive statistics
Incidence of laboratory abnormalities
时间窗: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
To be summarized using descriptive statistics
Incidence of dose limiting toxicities
时间窗: Up to 28 days
To be summarized using descriptive statistics
次要结局
- Objective response rate (ORR) as assessed by the investigator per RECIST v1.1(Up to approximately 3 years)
- Area under the concentration-time curve (AUC)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)
- Progression-free survival (PFS)(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 3 years)
- Duration of objective response (DOR)(Up to approximately 3 years)
- Time to maximum concentration (Tmax)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)
- Incidence of antidrug antibodies (ADA)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)
- Maximum concentration (Cmax)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)
- Trough concentration (Ctrough)(Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years)