NCT07456046招募中1 期
A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-003 Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation
D3 Bio (Wuxi) Co., Ltd9 个研究点 分布在 3 个国家目标入组 42 人开始时间: 2026年5月29日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 9
- 主要终点
- Number of Participants with Dose-Limiting Toxicities (DLTs)
研究概览
简要总结
This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of D3S-003 in participants with advanced KRAS p.G12D mutant 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
- •Subjects must have histologically confirmed locally advanced, recurrent, or metastatic malignancy that has failed to respond to adequate standard treatment(s), or for which no effective standard treatment is available.
- •Subjects must have documented presence of KRAS p.G12D mutation by a local test identified through tumor tissue or blood collected within the last 5 years.
- •Subjects must have measurable disease per RECIST v1.
- •Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subject must have adequate organ and marrow function within the screening period.
排除标准
- •Participant has any prior treatment with a specific KRAS G12D inhibitor/degrader or pan RAS inhibitor/degrader.
- •Subject has uncontrolled intercurrent illness, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, ongoing or active infections, uncontrolled or significant cardiovascular disease, autoimmune or inflammatory disorders or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs), or compromise the ability of the subject to give written consent.
- •Uncontrolled or untreated brain metastases
- •Subject has active gastrointestinal disease or other that could interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy
- •NOTE: Other protocol inclusion/exclusion criteria may apply.
研究组 & 干预措施
D3S-003
Experimental
Part 1a Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Once Daily Dosing)
Part 1b Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Twice Daily Dosing)
干预措施: D3S-003 (Drug)
结局指标
主要结局
Number of Participants with Dose-Limiting Toxicities (DLTs)
时间窗: From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.
Number of Participants with Adverse Events (AEs)
时间窗: From screening visit until 30 days after the last dose (or specified in the protocol)
Maximum tolerated dose (MTD) based on dose limiting toxicities (DLTs)
时间窗: First dose up to 7 months
Phase 2 dose (RP2D)
时间窗: First dose up to 7 months
次要结局
- D3S-003 concentration of drug immediately before the administration of next dose (Ctrough)(First dose up to 7 months)
- D3S-003 maximum observed plasma concentration (Cmax)(First dose up to 7 months)
- D3S-003 time to maximum plasma concentration (tmax)(First dose up to 7 months)
- D3S-003 half-life (t1/2)(First dose up to 7 months)
- D3S-003 area under the concentration-time curve (AUC)(First dose up to 7 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 7 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 7 months))
- Disease Control Rate (DCR) 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 7 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 7 months))
研究者
研究点 (9)
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