NCT05229900终止1 期
A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 43
- 试验地点
- 13
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
This study will test the safety of a drug called SGN-ALPV in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have three parts. Parts A and B of the study will find out how much SGN-ALPV should be given to participants. Part C will use the dose and schedule found in Parts A and B to find out how safe SGN-ALPV is and if it works to treat solid tumor cancers.
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
- •Participants must have one of the following histologically or cytologically confirmed metastatic or unresectable solid tumor types:
- •Parts A and B
- •Ovarian cancer
- •Endometrial cancer
- •Non-small cell lung cancer (NSCLC)
- •Gastric cancer, including gastroesophageal junction (GEJ) carcinoma
- •Cervical cancer
- •Malignant testicular germ cell tumor (GCT), except for pure teratomas
- •Malignant ovarian GCT, except for pure teratomas
- •Malignant extragonadal GCT except for pure teratomas or tumors with primaries arising from CNS
- •High-grade serous ovarian cancer (HGSOC): Participants must have HGSOC which has progressed or relapsed within 6 months after previous platinum containing chemotherapy, received 2 to 4 prior anticancer lines of therapy, and at least 1 line of therapy in the platinum-resistant setting. If eligible at least 1 line of therapy must have contained bevacizumab or a biosimilar to bevacizumab.
- •Endometrial Cancer: Participants must have unresectable locally advance or metastatic endometrial carcinoma and have had at least 1 prior line of therapy.
- •NSCLC: Participants must have unresectable locally advanced or metastatic NSCLC and have received platinum-based therapy and a PD-(L)1 inhibitor.
- •Gastric cancer or GEJ carcinoma: Participants must have unresectable locally advanced or metastatic gastric cancer or GEJ carcinoma and have received prior platinum and fluoropyrimidine -based chemotherapy
- •Participants enrolled in the following study parts should have an appropriate tumor site and agree to a biopsy
- •Part B dose and schedule optimization cohorts and Part C disease-specific expansion cohorts: pretreatment biopsy, unless clinically infeasible following consultation with the medical monitor.
- •Part C biology expansion cohort: pretreatment biopsy (required), on-treatment biopsy during Cycle 1 (unless clinically infeasible following consultation with the medical monitor)
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Measurable disease per the RECIST v1.1 at baseline
排除标准
- •History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- •Known active central nervous system metastases.
- •Previous receipt of an MMAE-containing agent or an agent targeting ALPP or ALPPL
- •Pre-existing neuropathy ≥ Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
研究组 & 干预措施
SGN-ALPV
Experimental
SGN-ALPV monotherapy
干预措施: SGN-ALPV (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Through 30-37 days after last study treatment, approximately 6 months
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities
时间窗: Through 30-37 days after last study treatment, approximately 6 months
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Up to 28 days
Number of participants with DLTs by dose level
时间窗: Up to 28 days
次要结局
- Area under the concentration-time curve (AUC)(Through 14 days after last study treatment, approximately 6 months)
- Incidence of antidrug antibodies (ADAs)(Through 30-37 days after last study treatment, approximately 6 months)
- Maximum concentration (Cmax)(Through 14 days after last study treatment, approximately 6 months)
- Time to Cmax (Tmax)(Through 14 days after last study treatment, approximately 6 months)
- Apparent terminal half-life (t1/2)(Through 14 days after last study treatment, approximately 6 months)
- Trough concentration (Ctrough)(Through 14 days after last study treatment, approximately 6 months)
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)(Approximately 2 years)
- Duration of objective response (DOR)(Approximately 2 years)
- Progression-free survival (PFS)(Approximately 2 years)
- Overall survival (OS)(Approximately 2 years)
- CA-125 response rate according to Gynecological Cancer Intergroup (GCIG) criteria (subjects with ovarian cancer only)(Approximately 2 years)
- Combined RECIST/CA-125 overall response rate according to GCIG (subjects with ovarian cancer only)(Approximately 2 years)
研究者
研究点 (13)
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