A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN1012 in Subjects With Unresectable or Metastatic Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
To evaluate CAN1012(Selective TLR7 agonist) when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy.
详细描述
This is a Phase 1, open-label, first-in-human, single-arm, multicenter, dose escalation study of IT CAN1012 in subjects with advanced solid tumors who are not candidates for standard therapy.
Subjects will be enrolled in cohorts of 3 at each dose level using a 3+3 dose escalation design Approach.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide written informed consent and willing to comply with the study's requirements.
- •Male or female age >18 years at screening.
- •Metastatic or locally advanced solid tumor that has progressed on, is refractory to, or for which there is no efficacious standard of care therapy.
- •Demonstrate adequate organ function as defined below. All screening laboratory assessments should be performed within 14 days of treatment initiation.
- •Performance status of 0 or 1 on the ECOG Performance Scale.
- •Life expectancy >12 weeks at Baseline.
- •Women of childbearing potential must have negative serum pregnancy test within 3 days prior to receiving the first study drug administration.
- •For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 120 days following last day of study drug administration.
- •Male subjects of childbearing potential must be surgically sterile or must agree to use adequate method of contraception during the study and at least 120 days following the last day of study drug administration.
排除标准
- •Received prior TLR7/8 agonists (excluding topical agents).
- •Has untreated or uncontrolled central nervous system (CNS) involvement.
- •Will receive concurrent chemotherapy, immunotherapy, biologic, hormonal therapy, or other therapies for cancer.
- •Received systemic interferon alfa (IFNα) prior to enrollment.
- •Unresolved toxicities from prior therapy, defined as having not resolved to CTCAE v5.0 Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.
- •Treatment with systemic corticosteroids.
- •Concomitant or planned use of sensitive substrates of major cytochrome P450 enzymes.
- •Has an active infection requiring systemic therapy.
- •Has known active infection with the human immunodeficiency virus,
- •Unstable/inadequate cardiac function.
- •Uncontrolled concurrent illness.
- •A history of interstitial lung disease.
- •A history of coagulopathy resulting in uncontrolled bleeding or other bleeding disorders.
- •Participated in a clinical study of an investigational agent within 30 days of screening.
- •Has known psychiatric, substance abuse, or other disorders that would interfere with cooperation with the requirements of the study in the opinion of the investigator.
- •Is pregnant or breastfeeding.
研究组 & 干预措施
CAN1012 single agent
CAN1012 intratumoral injection given alone
干预措施: CAN1012 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: 12 months
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE v5.0).
Recommended Phase 2 Dose (RP2D)
时间窗: 12 months
To determine a recommended phase 2 dose of CAN1012 for further development by evaluating number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Safety and Tolerability
时间窗: 12 months
Safety and tolerability as determined by assessment of dose limiting toxicities and the maximum tolerated dose or maximal assessed dose per protocol of CAN1012 with cancers.
次要结局
- tumor size in injected lesions and non-injected lesions(12 months)
- PK characterization - Cmax(12 months)
- PK characterization - tmax(12 months)