NCT07657806招募中1 期
A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer
Hangzhou DAC Biotechnology Co., Ltd.8 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年8月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is an open-label, multicenter Phase 1 study of DEC003M, in patients with advanced stage prostate cancer. The study consists of a dose-escalation phase to determine the dose for expansion, followed by a dose-expansion phase to evaluate preliminary antitumor activity, safety, and pharmacokinetics.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •At the time of informed consent, be ≥18 years of age.
- •Histologically confirmed adenocarcinoma of the prostate.
- •Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression despite androgen deprivation therapy.
- •Prior orchiectomy or medical castration, or continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) .
- •Measurable disease prior to enrollment.
- •Testosterone at castration level.
- •Progressed on standard therapy, or intolerant to standard therapy, or ineligible for standard therapy, or no standard therapy available.
- •At least 1 prior Androgen Receptor Pathway Inhibitor.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •History of other malignancies.
- •Inadequate organ function.
- •Active autoimmune disease.
- •Active CNS involvement.
- •Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
- •Any prior medical history of ILD/pneumonitis.
- •Clinically significant corneal disorder or known severe dry eye.
- •Grade 2 or higher peripheral neuropathy.
- •Inadequate washout period for prior anticancer treatment.
- •Any known history of or suspicion for history of clinically significant liver disease .
- •Known hypersensitivity to any component of the DEC003M.
- •Prior treatment with a PSMA-targeted antibody therapy.
- •Other conditions judged by the investigator that may have effects on the patient's participation in the study.
研究组 & 干预措施
Experimental
Experimental
DEC003M-001
干预措施: DEC003M (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: 3 weeks
Recommended Dose for Expansion (RDE)
时间窗: Up to 24 months
Adverse event
时间窗: Screening up to study completion, an average of 1 year.
次要结局
- Objective Response Rate（ORR）(Up to 24 months)
- PSA response rate(Up to 24 months)
- overall survival (OS)(Up to 36 months)
- Radiographic Progression-Free Survival (rPFS)(Up to 24 months)
研究者
研究点 (8)
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