NCT07265622招募中1 期
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of 7MW4911 in Patients With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence and rates of adverse events
研究概览
简要总结
This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Life expectancy ≥ 3 months.
- •Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.
- •Disease progression after the most recent treatment regimen.
- •At least one measurable lesion according to RECIST v1.
- •Provision of archival tumor tissue or fresh biopsy.
- •Adequte hematologic funciton, liver function and renal function.
- •Comply with contraceptive requirements.
排除标准
- •Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
- •Active, untreated or symptomatic CNS metastasis.
- •Effusions that require frequent drainage.
- •Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
- •Severe respiratory disease that required hospitalization in the last 28 days.
- •Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration.
- •Poorly controlled blood glucose with fasting blood glucose above 10 mmol/L.
- •Recipient of allogeneic stem cell transplant or organ transplant
- •Active HIV or hepatitis B/C infection. Infection requiring systemic IV in the 14 days prior to study drug administration.
- •Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.
- •Prohibited treatment and treatment that requires washout period: (1) Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy. (2) Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration. (3) Major surgeries within 28 days prior to study drug administration. (4) Investigational therapy within 28 days prior to study drug administration. (5) Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed. (6) Use of strong CYP3A4 inhibitor or inducer.
- •Known hypersensitivity to 7MW4911 or components of the formulation.
- •Abuse of narcotic or psychoactive drugs.
- •Pregnant or breastfeeding women.
- •Other circumstances or conditions where the investigator judges to be unsuitable for study.
研究组 & 干预措施
7MW4911
Experimental
干预措施: 7MW4911 (Drug)
结局指标
主要结局
Incidence and rates of adverse events
时间窗: Up to approximately 2 years
To assess the safety and tolerability of 7MW4911 in patients with advanced colorectal cancer and other advanced gastrointestinal tumors
Maximum tolerated dose (MTD), recommended expansion dose (RED) and the recommended phase II dose (RP2D)
时间窗: Up to approximately 2 years
To determine the maximum tolerated dose (MTD) and recommended expansion dose (RED) or the recommended phase II dose (RP2D)
次要结局
- Objective response rate(Up to approximately 2 years)
- Progression-free survival(Up to approximately 2 years)
- Immunogenicity(Up to approximately 2 years)
- Tmax(Up to 3 months)
- Cmax(Up to 3 months)
- t1/2(Up to 3 months)
- Area under the curve(Up to 3 months)
研究者
研究点 (1)
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