NCT07216560招募中1 期
A Phase I/II Study of 7MW4911 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Advanced Colorectal Cancer and Other Advanced Gastrointestinal 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
- 6
- 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 US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Aged 18 and above
- •Life expectancy ≥ 3 months
- •Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.
- •Disease progression after the most recent treatment regimen
- •At least one measurable lesion according to RECIST v1.1
- •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 10mmol/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
- •Has received another Topo-I payload ADC, and/or another CDH17 targeting therapy.
- •Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration.
- •Major surgeries within 28 days prior to study drug administration
- •Investigational therapy within 28 days prior to study drug administration
- •Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed.
- •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
MTD, RED, and 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
- Tmax of 7MW4911(up to 3 months)
- Cmax of 7MW4911(up to 3 months)
- Half life of 7MW4911(up to 3 months)
- Area under the curve of 7MW4911(up to 3 months)
- Objective response rate(Up to approximately 2 years)
- Progression-free survival(up to approximately 2 years)
- Immunogenicity of 7MW4911(Up to approximately 2 years)
研究者
研究点 (6)
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