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
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.
研究者
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)