NCT05628857已完成2 期
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of RC108 for Injection in the Treatment of Patients With c-Met-positiveAdvanced Digestive System Malignant Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
A multi-center, open-label, study designed to evaluate the preliminary efficacy, safety and pharmacokinetics of RC108 in patients with c-Me-positive advanced digestive system malignancies.
详细描述
The primary purpose of this trial is to evaluate the preliminary efficacy, safety and efficacy of RC108 in patients with c-Me positive advanced gastrointestinal malignancies such as gastric, colorectal, esophageal, hepatic, pancreatic and bile duct cancers.
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
- •Voluntary agreement to provide written informed consent.
- •Male or female, aged between 18 to 75 years.
- •Predicted survival for ≥ 12 weeks. Diagnosed with histologically or cytologically confirmed locally advanced or metastatic Digestive System Malignant Tumor.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
- •Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
- •Adequate organ function, evidenced by the following laboratory result Participant has adequate bone marrow, renal, and hepatic function.
- •bone marrow function: Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10^9 /L Platelets ≥ 100×10^9 /L.
- •hepatic function: Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis
- •renal, and hepatic function: Serum creatinine ≤1.5×ULN.
- •Cardiac ejection fraction ≥ 50%. Median QTc < 450 ms.
- •c-Met positive as confirmed by the central laboratory.
- •Measurable lesion according to RECIST 1.1.
排除标准
- •Known hypersensitivity to the components of RC108-ADC.
- •Toxicity of previous anti-tumor treatment not recovered to CTCAE (v5.0) Grade 0-1 (with exception of Grade 2 alopecia).
- •Uncontrolled pericardial effusion or cardiac tamponade, or pleural or abdominal effusion with clinical symptoms.
- •History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
- •History of major surgery within 4 weeks of planned start of trial treatment.
- •Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- •Currently known active infection with HIV or tuberculosis.
- •Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- •History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- •Known central nervous system metastases.
- •Uncontrolled hypertension, diabetes, pulmonary fibrosis, acute lung disease, Interstitial lung disease, or liver cirrhosis;
- •Pregnancy or lactation.
- •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
Cohort 1
Experimental
gastric cancer patients
干预措施: RC108 (Drug)
cohort 2
Experimental
colorectal cancer patients
干预措施: RC108 (Drug)
cohort 3
Experimental
liver cancer patients
干预措施: RC108 (Drug)
cohort 4
Experimental
other digestive system malignancies, including esophageal cancer, pancreatic cancer, gallbladder cancer, etc.
干预措施: RC108 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to 24 Months
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
次要结局
- Adverse Events(Up to 24 Months)
- Maximum observed plasma concentration (Cmax)(Up to 24 Months)
- Time to Cmax (Tmax)(Up to 24 Months)
- Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)(Up to 24 Months)
- DCR(Up to 24 Months)
- TTP(Up to 24 Months)
- OS(Up to 5 years)
- Terminal elimination half life(Up to 24 Months)
- DOR(Up to 24 Months)
- PFS(Up to 24 Months)
研究者
研究点 (2)
Loading locations...
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