NCT06797999招募中1 期
A First-in-human, Phase 1/2, Multicenter, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of ADCE-D01, a Humanized Anti-human uPARAP Antibody Linked to a Topoisomerase I Inhibitor, in Patients With Metastatic and/or Unresectable Soft Tissue Sarcoma
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Adcendo ApS
- 入组人数
- 270
- 试验地点
- 13
- 主要终点
- Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.
研究概览
简要总结
The goal of this clinical trial is to learn about the safety, tolerability and efficacy of ADCE-D01.
详细描述
Safety and Tolerability evaluated by incidence of DLTs. Efficacy evaluated by antitumor activity; ORR, DOR, PFS, CBR and TTR per RECIST v i.1.
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
- •≥ 18 years of age
- •Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
- •Prior treatment with at least one but no more than two lines of cytotoxic systemic therapy for metastatic/unresectable disease.
- •Measurable disease as per RECIST v 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy of at least 3 months.
- •A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate.
- •A female patient is eligible if not pregnant, not breast feeding, and not a woman of childbearing potential (WOCBP), or agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment.
排除标准
- •Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
- •Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement.
- •Clinically significant cardiovascular disease
- •Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV
- •Current active liver disease due to hepatitis B
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.
研究组 & 干预措施
ADCE-D01
Other
ADCE-D01
干预措施: Antibody-drug conjugate (ADC) (Biological)
结局指标
主要结局
Determine the MTD/maximum administered dose and RP2DS of ADCE-D01.
时间窗: From enrollment to the end of Phase 1b (Approximately 18 months after enrollment)
Measuring incidence of dose-limiting toxicities (DLTs)
Assess the safety and tolerability of ADCE-D01
时间窗: Throughout the trial duration, completion expected approximately 18 months from completed enrollment
Nature, incidence, severity and causality of treatment-emergent adverse events (TEAEs) and changes from baseline in laboratory parameters using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0). Tolerability as assessed by TEAEs leading to dose interruption, reduction and/or discontinuation.
次要结局
- Maximum concentration (Cmax)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- ADCE-D01 time to Cmax (Tmax)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Evaluate ADCE-D01 duration of response (DOR)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- ADCE-D01 area under the concentration-time curve (AUC)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- Evaluate ADCE-D01 objective response rate (ORR)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- ADCE-D01 clinical benefit rate (CBR)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
- ADCE-D01 progression-free survival (PFS)(Throughout the trial duration, completion expected approximately 18 months from completed enrollmen)
- ADCE-D01 time to response (TTR)(Throughout the trial duration, completion expected approximately 18 months from completed enrollment)
研究者
研究点 (13)
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