NCT07622524招募中1 期
A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti Tumor Activities of CS5007, a Novel EGFR and HER3 Bispecific Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 310
- 试验地点
- 11
研究概览
简要总结
This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.
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
- •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.
- •Being ≥ 18 years of age on the day of signing informed consent.
- •Pathologically or cytologically confirmed, unresectable advanced solid tumors.
- •Participants must have at least one measurable lesion according to RECIST Version1.
- •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
- •Adequate organ function.
- •Life expectancy ≥ 3 months.
- •Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration
排除标准
- •Has disease that is suitable for local treatment administered with curative intent.
- •Has a 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 symptomatic, untreated, or requires therapy.
- •Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.
- •Has uncontrolled pleural effusion, pericardial effusion, or ascites.
- •Has immune deficient disease or received systemic immunosuppressive treatment.
- •Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea.
- •Has history of (non-infectious) interstitial lung disease/pneumonitis that required steroids.
- •Has active infections requiring systemic therapy.
- •Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose.
- •Insufficient washout from prior anti-tumor therapy.
- •Received live vaccine within 28 days prior to first dose.
- •History of allogeneic organ or hematopoietic stem cell transplantation.
- •History of hypersensitivity to excipients of study drug or any monoclonal antibody.
- •Any toxic effects of prior therapy unresolved to Grade ≤
- •Active alcohol or drug abuse.
- •Pregnant or breastfeeding women.
- •Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.
研究组 & 干预措施
Dose Expansion
Experimental
Participants will be administered the recommended dose(s) of CS5007 according to dose-escalation data.
干预措施: CS5007 (Drug)
Dose Escalation
Experimental
Participants will be administered escalating doses of CS5007.
干预措施: CS5007 (Drug)
研究者
研究点 (11)
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