A Phase I/II, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1/VEGFA/CTLA-4, as Monotherapy and Combination Therapy in Participants With Advanced Solid Tumors

CStone Pharmaceuticals35 个研究点分布在 2 个国家目标入组 660 人2025年2月24日

概览

阶段: 1 期
干预措施: CS2009
疾病 / 适应症: Advanced Solid Tumors
发起方: CStone Pharmaceuticals
入组人数: 660
试验地点: 35
主要终点: [Dose Escalation] Maximum tolerated dose (MTD) of CS2009
状态: 招募中
最后更新: 17天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

概览

简要总结

This is a first-in-human (FIH), open-label, and multi-center Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.

注册库

clinicaltrials.gov

开始日期

2025年2月24日

结束日期

2028年1月1日

最后更新

17天前

研究类型

Interventional

研究设计

Sequential

性别

All

研究者

发起方

CStone Pharmaceuticals

责任方

Sponsor

入排标准

入选标准

•Evidence of a personally signed and dated informed consent document.
•Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
•Age ≥ 18 years on the day of signing informed consent.
•Pathologically or cytologically confirmed, unresectable advanced solid tumors, including but not limited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), gastric cancer (GC), ovarian cancer (OC), cervical cancer (CC), etc.
•Failure of established standard of care for advanced disease, or no available standard of care.
•Pathologically or cytologically confirmed unresectable advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), etc.
•Participants with at least one measurable lesion as defined per RECIST v1.1 solid tumor.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Adequate organ function.
•Fertile male participants and female participants of childbearing potential must be willing to use an effective method of birth control from providing signed consent and for 180 days after the last investigational product administration.

排除标准

•History of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
•Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.
•Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 4 weeks prior to the first dose of investigational product.
•Receipt of systemic corticosteroid treatment or any other form of immune suppressing treatment within 7 days prior to the first dose of investigational product.
•Active or prior history of definite inflammatory bowel disease.
•History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or presence of active or suspected ILD/pneumonitis.
•Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.
•Positive for human immunodeficiency virus (HIV) or presence of acquired immune deficiency syndrome (AIDS).
•Active Hepatitis B or C infection.
•Active pulmonary tuberculosis (TB).

研究组 & 干预措施