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临床试验/NCT05779163
NCT05779163已完成1 期

A Multicenter, Open Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-033 in the Treatment of Patients With Advanced Malignant Tumors.

Nanjing Leads Biolabs Co.,Ltd6 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年4月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
26
试验地点
6
主要终点
Dose-limiting toxicities(DLT)

研究概览

简要总结

This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

详细描述

This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of patients with advanced malignant tumors,which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

The trial is divided into 2 parts: Phase 1 and Phase 2

Phase I study:

Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of dose escalation data.

Phase II study:

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
All
接受健康志愿者

入选标准

  • Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
  • Age ≥ 18 years old when signing the informed consent form;
  • The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1;
  • The expected survival time is at least 12 weeks;
  • According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion;
  • Subject has adequate organ and bone marrow function,Conforming to laboratory test results:
  • Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets,etc); Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

排除标准

  • Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
  • Patients with active infection and currently requiring intravenous anti-infective treatment;
  • Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention;
  • The patient has a Medical history of immunodeficiency, including HIV antibody positive;
  • Women during pregnancy or lactation;
  • The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

研究组 & 干预措施

LBL-033

Experimental

LBL-033 for Injection; Initial dose - MTD; Q2W

干预措施: LBL-033 for Injection (Drug)

结局指标

主要结局

Dose-limiting toxicities(DLT)

时间窗: At the end of Cycle 1(28 days after the first prespecified dose)

DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.

Maximum tolerated dose (MTD)

时间窗: At the end of Cycle 1(28 days after the first prespecified dose)

MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles

次要结局

  • Cmax(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
  • immunogenicity(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
  • Duration of Response(DOR)(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
  • Objective Response Rate (ORR)(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy.)
  • Tmax(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
  • Disease Control Rate(DCR)(From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (6)

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