NCT07070518招募中1 期
An Open-Label Phase 1/2A Study of GV20-0251 in Participants With Advanced and/or Refractory Solid Tumor Malignancies
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
- 350
- 试验地点
- 3
- 主要终点
- Evaluate anti-tumor activities with GV20-0251
研究概览
简要总结
This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.
详细描述
This is a Phase 1/2A non-randomized, open-label, multi-center study to be conducted in 2 parts (A and B).
Part A is a safety run-in portion. A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).
In Part B, the Simon 2-stage design will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D across multiple expansion cohorts involving eligible participants.
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
- •Before conducting any study-specific procedures, voluntarily sign an informed consent form.
- •Be able and willing to participate throughout the entire study period and comply with study procedures.
- •participants ≥18 years of age
- •Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)
- •Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
- •For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
- •ECOG performance status of 0 or 1 before C1D1
- •Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible
- •Disease-free of active second/secondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters
- •Women of childbearing potential (WOCBP) and men must agree to use adequate contraception
排除标准
- •Participants with acute leukemia or CLL
- •Participant with heart disease (NYHA ≥ Level II), myocardial infarction within the past 6 months, or unstable arrhythmia
- •Fridericia-corrected QT interval (QTcF) > 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.
- •Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days before C1D1
- •Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
- •Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.
- •History of major organ transplant and/or a bone marrow transplant
- •Symptomatic central nervous system (CNS) malignancy or metastasis
- •Serious nonmalignant disease
- •Pregnant or nursing women
- •Major surgery within 28 days prior to the first dose of study medication
- •Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions.
- •History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.
- •Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.
- •Active substance abuse
- •Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy
研究组 & 干预措施
GV20-0251
Experimental
干预措施: GV20-0251 (Drug)
结局指标
主要结局
Evaluate anti-tumor activities with GV20-0251
时间窗: From Cycle 1 Day 1 dosing (each cycle is 21 days) until disease progression or end of study (whichever occurs first, up to 24 months)
Objective Response Rate (ORR) assessed by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
次要结局
未报告次要终点
研究者
研究点 (3)
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