NCT06410703招募中1 期
A Phase Ib/IIa, Dose Escalation, Open-Label Study of Intratumoral CAN1012 Combined With PD-1 in Patients With Unresectable or Metastatic Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a Phase Ia/IIb, open-label, first-in-human, multicenter, single-arm, dose escalation study of intratumoral CAN1012 combined with PD-1 in patients with Unresectable or Metastatic Advanced Solid Tumors who have exhausted options for standard of care therapy.
详细描述
The scope of the study is to evaluate the safety of the combination therapy of CAN1012 and PD-1 in human, study its efficacy and pharmacokinetics profiles, as well as explore its pharmacodynamic effects and biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •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.
- •Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists.
- •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:
- •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 >450msec（male），>470msec（female）.
- •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(0.01mg)+Toripalimab(240mg)
Experimental
CAN1012(0.01mg)+Toripalimab(240mg)
干预措施: CAN1012 (Drug)
CAN1012(0.017mg)+Toripalimab(240mg)
Experimental
CAN1012(0.017mg)+Toripalimab(240mg)
干预措施: CAN1012 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 1 year
Safety and tolerability as determined by assessing dose limiting toxicities, the maximum tolerated dose or maximal assessed dose per protocol in combination with toripalimab (anti-PD-1) with patients.
次要结局
- To determine the MTD and or RP2D of CAN1012 Combined with PD-1(Monitor a tumor response to the combination therapy according to RECIST 1.1 or iRECIST 1.1 as appropriate.)
- To determine the Pharmacokinetics of CAN1012 Combined with PD-1(1 year)
研究者
研究点 (1)
Loading locations...
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