A Phase 1, Dose Escalation, Open-Label Study of Intratumoral CAN2109 in Subjects With Unresectable or Metastatic Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
A phase 1, dose escalation, open-label study of intratumoral CAN2109 in subjects with unstable or metastatic advanced solid tumors or lymphomas.
详细描述
The scope of the study is to evaluate the safety of CAN2109 in humans, explore its safety, efficacy and collect data on the pharmacokinetics, as well as on the pharmacodynamic effect of the drug on the immune system locally and systemically, and on tumor markers.
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
- •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. Preferred tumor types include the following:
- •a. Carcinoma of skin, melanoma, Merkel cell carcinoma (MCC), breast cancer, head and neck squamous cell carcinoma (HNSCC), sarcoma, cervical carcinoma, and colorectal cancer
- •Performance status of 0-1 on the ECOG Performance Scale.
排除标准
- •Unresolved toxicities from prior therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0) Grade 0 or 1, with exception of endocrinopathies from prior therapy, alopecia, and vitiligo.
- •Treatment with systemic corticosteroids at doses exceeding 10 mg/day prednisone or equivalent.
- •Has an active infection requiring systemic therapy.
- •Unstable/inadequate cardiac function defined as follows:
- •New York Heart Association Class 3 or 4 congestive heart failure
- •uncontrolled hypertension
- •acute coronary syndrome within 6 months
- •clinical important cardiac arrhythmia
- •mean corrected QT (QTc) interval corrected for heart rate > 480 ms.
- •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
CAN2109
CAN2109 IT injection every three weeks (Q3W)
干预措施: CAN2109 (Drug)
结局指标
主要结局
Safety
时间窗: 12 months
determined by assessment of dose limiting toxicities per protocol of CAN2109 with cancers.
Recommended Phase 2 Dose (RP2D)
时间窗: 12 months
To determine a recommended phase 2 dose of CAN21909 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).
tolerability
时间窗: 12 months
determined by assessment of the maximum tolerated dose or maximal assessed dose per protocol of CAN2109 with cancers.
次要结局
- To determine the efficacy of CAN2109(12 months)
- To evaluate the pharmacodynamics of CAN2109(12 months)