A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of ABO2102 in Participants With KRAS Mutant Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab
研究概览
简要总结
This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.
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
- •≥18 years of age at time of informed consent.
- •Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations
- •Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors.
- •According to RECIST v1.1, at least one measurable lesion is required.
- •No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol.
- •Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception.
排除标准
- •Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
- •Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .
- •Received KRAS cancer vaccine before.
- •History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.
- •History of allogeneic organ transplantation or graft-versus-host disease (GVHD).
- •Any active infection (except for hepatitis virus infection) requires systemic treatment.
- •Absence of spleen
- •Known psychiatric disorder or drug abuse that may interfere with the trial requirements
- •Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study.
- •Other conditions that Investigators consider inappropriate for enrollment.
研究组 & 干预措施
ABO2102 Injection
Monotherapy
干预措施: ABO2102 Injection (Drug)
ABO2102 Injection and Sintilimab Injection
ABO2102 Injection in combination with Sintilimab Injection
干预措施: ABO2102 Injection (Drug)
ABO2102 Injection and Sintilimab Injection
ABO2102 Injection in combination with Sintilimab Injection
干预措施: Sintilimab injection (Drug)
结局指标
主要结局
Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab
时间窗: 28 days after the first dose of study treatment
Part I: Incidence and severity of adverse events
时间窗: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy
Part II: ORR evaluated by investigators according to RECIST v1.1 criteria
时间窗: from the first dose of study treatment to up to 3 years
Part II: PFS evaluated by investigators according to RECIST v1.1 criteria
时间窗: from the first dose of study treatment to up to 3 years
次要结局
未报告次要终点