NCT05099536撤回1 期
A Phase I Study of the Safety, Tolerability, Pharmacokinetics Profiles and Preliminary Efficacy of 3D011-08 for Injection Monotherapy in Subjects With Advanced Solid Tumors
3D Medicines (Beijing) Co., Ltd.1 个研究点 分布在 1 个国家开始时间: 2022年2月24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
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The purpose of this study is evaluate the the safety, tolerability, pharmacokinetics profiles, and preliminary efficacy of 3D011-08 in subjects with advanced solid tumors.
详细描述
Detailed Description: This study was initiated on February 24, 2022, at Fudan Cancer Hospital. However, noparticipants were screened or enrolled after the initiation. Due to strategic development adjustments, thecompany terminated the study on September 11. 2023.
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
- •Histologically or cytologically confirmed locally advanced or metastatic malignant solid tumors(part 1 dose escalation); Histologically confirmed locally advanced or metastatic hepatocellular carcinoma (cohort 1),advanced renal cell carcinoma (cohort 2), and metastatic castration-resistant prostate cancer (cohort 3) for which not amenable to local therapy.(part 2 dose expansion).
- •Cohort 1 and 2: at least one measurable lesion (according to RECIST 1.1 criteria);Cohort 3: at least one measurable or unmeasurable lesion (according to RECIST 1.1 criteria).
- •Subjects must have failed or have been intolerant to established standard therapies, or standard therapies did not exist or were no longer effective for a given tumor type, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds(part 1 dose escalation). Cohort 1 (advanced hepatocellular carcinoma)and Cohort 2 (advanced renal cell carcinoma): Subjects had disease progression after received previous first-line of systemic treatment, or subjects are intolerant of or have refused to receive first-line of systemic treatment.
- •Cohort 3 (metastatic castration-resistant prostate cancer) : Patients who had failed or had refused prior abiraterone and/or docetaxel chemotherapy.(part 2 dose expansion)
- •ECOG Performance Status ≤ 2(part 1 dose escalation).≤ 1.(part 2 dose expansion)
- •Life expectancy ≥ 12 weeks.
- •Adequate organ and bone marrow function.
排除标准
- •Investigational products or devices in other clinical trials or received antibody drug therapy within 4 weeks before the first dose,or chemotherapy, targeted therapies,or radiotherapy within 2 weeks before the first dose.
- •Participants need to continue using medications known to have a significant risk of causing QTc prolongation or a CYP3A4 strong inhibitor or strong inducer.
- •Participants who have previous toxicity of anti-tumor therapy that has not been returned to level 0 or
- •Participants with diseases at risk of bleeding within 3 months prior to enrollment
- •Participants with concomitant medical conditions requiring anticoagulant therapy at a therapeutic dose
- •History or current condition of uncontrolled cardiovascular disease.
- •Participants with gastrointestinal disease associated with a risk of perforation or fistula formation
研究组 & 干预措施
3D011-08
Experimental
干预措施: 3D011-08 (Drug)
结局指标
主要结局
ORR
时间窗: 24 Months
proportion of subjects in cohort 1 and cohort 2 who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators.
TTP
时间窗: 24 Months
time to progression based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) as assessed by investigators .
Maximum Tolerated Dose (MTD) of3D011-08
时间窗: 24 months
The maximum tolerated dose as determined in Part 1 of the study will be used as the recommended dose for Part 2.
次要结局
- CL(24 months)
- Vd(24 months)
- Tmax(24 months)
- AUC0~t、AUC0~∞(24 months)
- Ctrough(24 months)
- t1/2(24 months)
- ORR(24 months)
- Duration of response (DoR)(24 months)
- Disease control rate (DCR)(24 months)
- Progression-free survival (PFS)(24 months)
- Permeable surface area of capillary wall(PS)(24 months)
- RPTD(24 months)
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(24 months)
- Cmax Cmax(24 months)
- Css min(24 months)
- the incremental Area Under Curve (iAUC)(24 months)
研究者
研究点 (1)
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