NCT05108779招募中1 期
Phase Ia Clinical Study of Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLF32004 for Injection Monotherapy in Patients With Advanced Malignant Tumors
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
- 40
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicity (DLT)
研究概览
简要总结
To determine the safety, tolerability, and recommended dose (RP2D) of QLF32004 in patients with advanced malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Age: 18-75 years old .
- •Patients with advanced malignant solid tumors confirmed histologically or cytologically have failed standard therapy, or have no standard therapy, or are not eligible for standard therapy at this stage.
- •(dose escalation phase) At least one assessable tumor focus according to RECIST 1.1;(PK expansion phase) According to RECIST 1.1, there is at least one measurable tumor lesion (a tumor lesion located in the area of previous radiotherapy or other local regional treatment site is generally not considered measurable unless the lesion shows definite progression or persists after 3 months of radiotherapy).
- •ECOG score 0-
- •Life expectancy ≥ 12 weeks.
- •Adequate organ function prior to the first use of the investigational drug (no use of any blood components, cell growth factor, colony stimulating factor (G-CSF), rhTPO, etc., or hepatoprotective therapy is permitted within 14 days prior to laboratory examination);
- •Eligible fertile patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier methods or abstinence, etc.) with their partner during the trial and for 6 months after the last medication;Women of reproductive age must have a negative blood pregnancy test within 7 days of their first use of the study drug;
- •Subjects shall give informed consent to this study before the test and voluntarily sign a written informed consent.
排除标准
- •Known allergy to the study drug or any excipients thereof; Or had a grade ≥3 allergic reaction to protein drugs in the past.
- •Had received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to the first use of the study drug.
- •Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the first use of the investigational drug.
- •Use of live attenuated vaccine within 4 weeks prior to initial use of the study drug.
- •Received systemic glucocorticoid or other immunosuppressant treatment within 14 days prior to initial use of the study drug.
- •Use of immunomodulatory drugs, including but not limited to thymosin.
- •Had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to initial use of the study drug, or required elective surgery during the study period.
- •Patients with cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms were judged by the investigator to be unsuitable for inclusion;
- •Patients with uncontrollable exudation (thorax, pericardium, abdominal cavity);
- •Have received immunotherapy and present with grade ≥ 3 irAE or grade ≥2 immune-associated myocarditis;
- •Adverse reactions of previous antitumor therapy have not recovered to CTCAE 5.0 rating ≤1 (except toxicity without safety risk, such as hair loss, peripheral neurotoxicity of grade 2, hypothyroidism stabilized by hormone replacement therapy, etc.);
- •Presence or history of any active autoimmune disease;Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, hair loss, type I diabetes, or asthma that has been completely resolved in childhood and does not require any intervention as adults may be included;Asthma patients requiring medical intervention with bronchodilators were excluded;
- •Patients with previous or current interstitial lung disease;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis B, active hepatitis C;
- •Have a history of serious cardiovascular and cerebrovascular diseases;
- •Have active infection and currently require intravenous anti-infection therapy;
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •The patient is known to have a history of psychotropic drug abuse, alcoholism or drug abuse;A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
- •Patients with other serious physical or mental disorders or abnormal laboratory tests that may increase the risk of study participation or interfere with study results, and who are considered unsuitable for study participation by the investigator.
研究组 & 干预措施
QLF32004
Experimental
干预措施: QLF32004 (Drug)
结局指标
主要结局
Dose-Limiting Toxicity (DLT)
时间窗: 21 days
Maximum Tolerated Dose (MTD)
时间窗: 21 days
Recommended Phase 2 Dose (RP2D)
时间窗: 12 month
次要结局
- Treatment-Emergent Adverse Event (TEAE)(21 days)
- Maximum Observed Plasma Concentration (Cmax)(21 days)
- Serious Adverse Event (SAE)(12 month)
- Area Under The Curve (AUC)(21 days)
研究者
研究点 (1)
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