A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC278 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 35
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D)， and assess the efficacy of RC278 at the RP2D dose;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
- •Age between 18 and 75 years (including 18 and 75 years);
- •ECOG PS score of 0 or 1;
- •Expected survival ≥12 weeks;
- •According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
- •Sufficient bone marrow, liver, kidney, and blood clotting function
排除标准
- •Pregnant, breastfeeding, or intending to become pregnant subjects.
- •Subjects with brain metastases.
- •Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade
- •Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
- •Subjects with acute, chronic, or symptomatic infections.
- •Subjects with uncontrolled cardiovascular diseases.
- •Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
- •Subjects with a history of cirrhosis (Child-Pugh B or C class).
- •Subjects with active inflammatory bowel disease.
- •Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
- •Subjects who experienced arterial/venous thromboembolic events, deep vein thrombosis, pulmonary embolism, or stroke within 6 months prior to the first dose.
- •Subjects with pericardial effusion or cardiac tamponade, or third-space fluid accumulation, which, in the investigator's judgment, cannot be controlled or stabilized by drainage or other methods.
- •Subjects with active autoimmune diseases requiring systemic treatment within the past 2 years.
- •Subjects with a history of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from a previously diagnosed malignancy.
- •Subjects with a history of other acquired or congenital immunodeficiency diseases or organ transplantation.
- •Subjects with a history or current diagnosis of uncontrolled psychiatric disorders.
- •Subjects with poor adherence, who are unlikely to comply with the trial procedures.
- •Subjects with any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities, which, in the investigator's judgment, raise suspicion of an underlying condition making the subject unsuitable for the investigational drug, or which may affect the interpretation of the study results, or place the subject at high risk.
研究组 & 干预措施
RC278 (Phase I, dose escalation)
There are five escalating dose cohorts.
干预措施: RC278 (Drug)
RC278 (Phase I, dose expansion)
The recommended dose from the dose-escalation stage and other potential doses will be further explored.
干预措施: RC278 (Drug)
RC278 (Phase I, dose optimization)
Based on the safety, pharmacokinetic (PK), and efficacy data from the subjects, select at least two dose levels and randomly assign subjects in a 1:1 ratio to determine the recommended Phase II dose (RP2D) for entering the Phase II stage.
干预措施: RC278 (Drug)
RC278 (Phase II)
In the multi-indication cohort expansion phase, further assess the efficacy and safety of RC278 in various cancer types using the RP2D.
干预措施: RC278 (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: 24 months
DLT is defined as the adverse events (AEs) occurring during the DLT observation period that the investigator determines to be related to the RC278 treatment.
Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v5.0)
时间窗: 24 months
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the CTCAE Version 5.0\].
Determine RP2D of RC278
时间窗: 24 months
To determine the RP2D for further evaluation of RC278 in subjects with advanced solid tumor.
MTD and/or MAD
时间窗: 24 months
To determine the MTD and/or MAD for further evaluation of RC278 in subjects with advanced solid tumor.
Investigator assessed ORR according to RECIST v1.1 criteria
时间窗: 24 months
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).
次要结局
未报告次要终点