NCT05957536招募中1 期
A Phase 1, Open-label Dose Escalation and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-001 Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors.
D3 Bio (Wuxi) Co., Ltd11 个研究点 分布在 3 个国家目标入组 128 人开始时间: 2023年9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
- 128
- 试验地点
- 11
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.
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
- •Subject must have documented HER2 positivity (determined by immunohistochemistry [IHC], in situ hybridization [ISH], Next Generation Sequencing [NGS] or other analysis techniques as appropriate).
- •Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subject must have left ventricular ejection fraction (LVEF) ≥50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within the screening period.
- •Subject must have adequate organ and marrow function within the screening period.
排除标准
- •Subject has any prior treatment with anti-CD47 or SIRPα agent.
- •Subject has any prior treatment without adequate washout periods as defined in the protocol.
- •Subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication.
- •Subject has uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the subject to give written informed consent.
- •Subject has unresolved treatment-related toxicities from previous anticancer therapy of NCI CTCAE Grade ≥2 (with exception of vitiligo or alopecia).
- •Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions, and requirements.
研究组 & 干预措施
D3L-001
Experimental
Part 1 Dose Escalation in subjects with HER2-positive advanced solid tumors
- Cohort 1 (starting dose)
- Cohort 2
- Cohort 3
- Cohort 4
- Cohort 5
- Cohort 6
- Cohort 7
- Cohort 8
Part 2 Dose Expansion
- Cohort A for subjects with HER2-positive advanced breast cancer
- Cohort B for subjects with HER2-positive advanced gastric cancer/gastroesophageal junction cancer
干预措施: D3L-001 (Biological)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Screening until Safety Follow Up visit (30 days after the last dose)
Maximum Tolerated Dose based on Dose-Limiting Toxicities (DLTs)
时间窗: At the end of Cycle 1 (each cycle is 21 days).
次要结局
- D3L-001 half-life (t1/2)(First dose up to 6 months)
- D3L-001 minimum serum concentration (Ctrough)(First dose up to 6 months)
- D3L-001 maximum observed plasma concentration (Cmax)(First dose up to 6 months)
- Incidence of anti-drug antibodies (ADA) to D3L-001(First dose up to 6 months)
- D3L-001 area under the concentration-time curve (AUC)(First dose up to 6 months)
- D3L-001 time to maximum plasma concentration (tmax)(First dose up to 6 months)
- Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)(Until disease progression or end of treatment (up to approximately 6 months))
- Duration of Response (DOR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)(Until disease progression or end of treatment (up to approximately 6 months))
- Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1(Until disease progression or end of treatment (up to approximately 6 months))
- Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)(Until disease progression or end of treatment (up to approximately 6 months))
研究者
研究点 (11)
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