NCT07327632招募中1 期
A Multi-Center, Open-Label, Phase 1 Study of IBI3026 in Participants With Locally Advanced, Unresectable or Metastatic Solid Tumors
Innovent Biologics Technology Limited (Shanghai R&D Center)1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年1月29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
- 300
- 试验地点
- 1
- 主要终点
- Adverse Event
研究概览
简要总结
This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3026 in participants with unresectable, locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have the ability to understand and sign a written informed consent form for participation in this study, including all assessments and procedures specified in the protocol;
- •Male or female participants aged ≥18 years;
- •At least one measurable lesion as defined by RECIST v1.1 within 28 days prior to the first dose of IBI3026;
- •ECOG performance status of 0-1;
- •Life expectancy of at least 12 weeks at the start of treatment;
- •The screening period confirms that bone marrow and organ functions are good.
- •Male or female participants who are either of non-reproductive potential or agree to use at least one highly effective method of contraception during the study period (starting from screening or 2 weeks prior to first dosing, whichever comes first, and continuing until 6 months after the last dose of study drug);
- •Not amenable to curative surgical resection or definitive chemoradiotherapy.
排除标准
- •Prior treatment with IL-12 class cytokines or IL-12 inhibitors;
- •Participation in any interventional clinical study other than observational (non-interventional) studies, or currently in the follow-up period of an interventional study;
- •Adverse reactions from prior anti-tumor therapies that have not resolved to Grade 0 or 1, or baseline levels, according to NCI CTCAE v5.0, prior to the first dose of study drug (exceptions include alopecia, fatigue, hyperpigmentation, or other conditions deemed without safety risk by the investigator);
- •Prior immune checkpoint inhibitor therapy associated with severe adverse reactions sufficient to compromise participant safety;
- •Known hypersensitivity, allergic reaction, or intolerance to IBI3026 or its excipients (refer to Investigator's Brochure).
- •Received major surgery (e.g., craniotomy, thoracotomy, or laparotomy, or other surgeries as determined by the investigator) within 4 weeks prior to the first dose of study drug, excluding core biopsy; or anticipated to undergo major surgery during the study period; or presence of serious non-healing wounds, trauma, ulcers, etc.
- •Known symptomatic central nervous system (CNS) metastases. Participants with asymptomatic CNS metastases (i.e., no neurological syndrome and metastatic lesion diameter ≤1.5 cm) or those with stable disease post-treatment as judged by the investigator may be considered under the following conditions: absence of midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord involvement; clinically stable for at least 4 weeks prior to the first dose of study drug (stable on ≤1.5 mg/day dexamethasone or equivalent corticosteroid and baseline anticonvulsant therapy), with no clinically confirmed new or enlarging CNS lesions.
- •Tumor invasion into surrounding critical structures (e.g., mediastinal vessels, superior vena cava, trachea, esophagus, etc.) or at risk of gastrointestinal/respiratory fistula formation.
研究组 & 干预措施
IBI3026
Experimental
干预措施: IBI3026 (Drug)
结局指标
主要结局
Adverse Event
时间窗: up to 2 years
Maximum Tolerated Dose
时间窗: up to 2 years
DLT(Dose-limiting Toxicity)
时间窗: up to 2 years
Serious Adverse Event
时间窗: up to 2 years
次要结局
- Incidence and number of patients with ADA(up to 2 years)
- Incidence and number of patients with NAb(up to 2 years)
- PK concentration: IBI3026 serum concentration(up to 2 years)
- DoR(Duration of Response)(up to 2 years)
- DCR(Disease Control Rate)(up to 2 years)
- TTR(Time to Response)(up to 2 years)
- ORR (Objective Response Rate)(up to 2 years)
- PFS(Progression-free Survival)(up to 2 years)
- OS(Overall Survival)(up to 2 years)
研究者
研究点 (1)
Loading locations...
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