NCT07667842招募中1 期
A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-002 (an Anti-TIGIT/Anti-PVRIG Bispecific Antibody) Monotherapy in Subjects With Advanced Solid Tumors
D3 Bio (Wuxi) Co., Ltd6 个研究点 分布在 2 个国家目标入组 24 人开始时间: 2026年7月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 6
研究概览
简要总结
This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy in subjects with advanced solid tumors. D3L-002 will be administered as an intravenous infusion every 3 weeks (Q3W) in 21-day cycles. Approximately 24 subjects will be enrolled. Dose escalation will follow a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
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
- •Ability to provide written informed consent and comply with study procedures
- •Age ≥18 years
- •Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Adequate organ function (hematologic, hepatic, renal)
- •Life expectancy ≥12 weeks
- •Willingness to provide tumor tissue (if available) and blood samples
- •Agreement to use effective contraception
- •Negative pregnancy test for participants of childbearing potential
排除标准
- •Prior anti-TIGIT or anti-PVRIG therapy
- •Recent anticancer therapy without adequate washout
- •Active or uncontrolled illness
- •Interstitial lung disease/pneumonitis
- •Active Central Nervous System (CNS) disease
- •Uncontrolled effusions
- •Unresolved ≥Grade 2 toxicities
- •Severe prior immunotherapy-related toxicity
- •Active autoimmune disease
- •Active infection
- •Active hepatitis B/C or HIV
- •Recent malignancy (exceptions apply)
- •Significant cardiovascular disease
- •Immunosuppressive therapy within 14 days
- •Live vaccine within 30 days
- •Pregnancy or breastfeeding
- •Hypersensitivity to study drug
- •Investigator-determined unsuitability
研究组 & 干预措施
D3L-002
Experimental
Dose Escalation
- Cohort 1 (starting dose)
- Cohort 2
- Cohort 3
- Cohort 4
干预措施: D3L-002 (Drug)
研究者
研究点 (6)
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