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临床试验/NCT05918445
NCT05918445
招募中
1 期

Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors

Biotheus Inc.14 个研究点 分布在 1 个国家目标入组 380 人2021年3月9日
干预措施PM8002
相关药物PM8002

概览

阶段
1 期
干预措施
PM8002
疾病 / 适应症
Malignant Neoplasm
发起方
Biotheus Inc.
入组人数
380
试验地点
14
主要终点
Treatment related adverse events (TRAEs)
状态
招募中
最后更新
去年

概览

简要总结

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.

注册库
clinicaltrials.gov
开始日期
2021年3月9日
结束日期
2025年11月30日
最后更新
去年
研究类型
Interventional
研究设计
Sequential
性别
All

研究者

发起方
Biotheus Inc.
责任方
Sponsor

入排标准

入选标准

  • Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
  • Male or female aged 18 to 75 years;
  • Patients with malignant tumor confirmed by histology or cytology;
  • The toxicity of previous anti-tumor therapy has not been alleviated;
  • Adequate organ function;
  • ECOG score was 0-1;
  • Expected survival \>=12 weeks;
  • According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally.

排除标准

  • History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
  • Evidence of major coagulopathy or other obvious risk of bleeding;
  • Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy;
  • Patients with uncontrolled brain metastases should be excluded from this clinical trial;
  • Patients ever experienced other active malignant tumors within 5 years prior to the study treatment;
  • Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
  • Syphilis antibody positive;
  • Patients with active tuberculosis (TB) are excluded;
  • Pregnant or lactating women;

研究组 & 干预措施

PM8002

PM8002 IV every 2 weeks(q2w) or every 3 weeks(q3w)

干预措施: PM8002

结局指标

主要结局

Treatment related adverse events (TRAEs)

时间窗: Up to 30 days after last treatment

The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

Number of participants with DLTs

时间窗: During the first three weeks of treatment with PM8002

DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, intercurrent illness, or concomitant medications that occurs within the first cycle (3weeks) of treatment.

Objective response rate (ORR)

时间窗: Up to approximately 2 years

Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.

次要结局

  • Anti-drug antibody (ADA)(Up to 30 days after last treatment)
  • Duration of response (DoR)(Up to approximately 2 years)
  • Overall survival (OS)(Up to approximately 2 years)
  • Progression-free survival (PFS)(Up to approximately 2 years)
  • Disease control rate (DCR)(Up to approximately 2 years)

研究点 (14)

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