NCT07537881招募中1 期
A Multicenter Phase I/II Clinical Study to Evaluate the Safety and Efficacy of RC288 for Injection in the Treatment of Locally Advanced Unresectable or Metastatic Malignant Solid Tumor.
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
- 326
- 试验地点
- 14
- 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 RC288; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC288; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC288 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 v6.0 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.
- •History of underlying pulmonary disease.
- •Subjects with a history of cirrhosis (Child-Pugh B or C class).
- •Clinically significant gastrointestinal disease.
- •Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
- •Occurrence of hemorrhagic events of Grade ≥2 per NCI CTCAE (v6.0) within 4 weeks prior to screening; or clinical manifestations suggestive of a significant bleeding tendency within 4 weeks prior to screening.
- •Imaging during the screening period shows tumor invasion or involvement of vital organs, with imaging evidence judged by the investigator to indicate a risk of bleeding or fistula formation.
- •History of arterial/venous thromboembolic events within 6 months prior to the first dose.
- •Presence of pericardial effusion or cardiac tamponade, or third-space fluid accumulation that, in the investigator's judgment, cannot be stably controlled by drainage or other methods.
- •History of active autoimmune disease requiring systemic therapy within the past 2 years.
- •History of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from any previously diagnosed malignancy.
- •History of other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- •History of or current poorly controlled psychiatric disorder.
- •Poor compliance, and patients who are expected to be unable to cooperate with the completion of trial procedures.
- •Presence of any other disease, metabolic abnormality, physical examination finding, or laboratory abnormality that, in the investigator's judgment, gives reasonable suspicion of a condition that contraindicates the use of the investigational drug, may affect the interpretation of study results, or places the patient at high risk.
- •Local or systemic diseases not caused by malignancy, or diseases or symptoms secondary to the tumor, which may lead to higher medical risks and/or uncertainty in survival assessment.
研究组 & 干预措施
RC288 (Phase II, dose expansion)
Experimental
In the multi-indication cohort expansion phase, further assess the efficacy and safety of RC288 in various cancer types using the RP2D.
干预措施: RC288 For Injection (Drug)
RC288 (Phase I, dose escalation)
Experimental
There are six predefined escalating dose levels.
干预措施: RC288 For Injection (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: 24 months
Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v6.0)
时间窗: 24 months
Determine RP2D of RC288
时间窗: 24 months
MTD and/or MAD
时间窗: 24 months
Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria and PCWG3 criteria
时间窗: 24 months
Non-Prostate Cancer Cohort: Investigator assessed ORR according to RECIST v1.1 criteria
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (14)
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