NCT07636707尚未招募1 期
An Open-label, Multicenter Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of QLF4113 for Injection in Participants With Metastatic Prostate Cancer.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 140
研究概览
简要总结
This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in participants with metastatic prostate cancer.
The Phase I trial consists of two parts: Phase Ia and Phase Ib. Phase Ia is a dose-escalation study of QLF4113 monotherapy to determine the recommended phase two dose and assess safety and PK. Then the study will proceed to Phase Ib, a dose-expansion study to further evaluate the preliminary efficacy and safety of QLF4113 monotherapy under the selected doses.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants voluntarily agree to participate and sign the informed consent form.
- •Male, aged ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
- •Life expectancy ≥ 3 months.
- •Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine carcinoma or small cell carcinoma features.
- •Confirmed metastatic Castration-Resistant Prostate Cancer (mCRPC).
- •Failed or are intolerant to standard therapies
- •Adequate function of major organs as defined by the protocol.
- •Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).
- •Prior to the first use of the investigational drug, recovery from all reversible adverse events (AEs) related to prior anticancer treatments
排除标准
- •Previously treated with drugs targeting CD3 or CD
- •Significant Cardiovascular Diseases
- •Active, Uncontrolled Infections
- •Immunosuppressive Treatment before the first dose of the investigational drug
- •Clinically Uncontrolled Third-Space Fluid Accumulation
- •History of Other Malignancies within 5 years prior to the first dose of the investigational drug
- •Moderate to Severe Pulmonary Diseases significantly affecting lung function,
- •Current Hepatic Encephalopathy, Hepatorenal Syndrome, or Cirrhosis classified as Child-Pugh B or worse.
- •Allergy to the Investigational Drug or its Components.
- •Any Condition deemed by the investigator to increase study-related risks, interfere with the interpretation of study results, or otherwise render the participant unsuitable for inclusion.
研究者
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