A Phase Ib/II Study of PM8002 Injection Plus Nab-paclitaxel as First Line Therapy for Unresectable, Locally Advanced or Metastatic Triple-negative Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Objective Response Rate
研究概览
简要总结
Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.
详细描述
PD-L1 and VEGF play important roles in immune escape and tumor angiogenesis and enhance cancer growth and metastasis. PM8002 is a bispecific antibody targeting PD-L1 and VEGF-A. Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures;
- •Male or female, aged 18 to 75 years (including boundary value);
- •Unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology, ER, PR, HER-2 are all negative. Negative ER and PR were defined as: IHCER < 1%, IHCPR < 1%. HER-2 negative is defined as: IHCHER-2 (-) or (1+), HER-2 (2+) must be tested by FISH and the result is negative.
- •Patients who have not received systemic treatment for advanced TNBC in the past are allowed to use taxane anti-tumor therapy in the previous neoadjuvant and/or adjuvant treatment stage, but must meet the end time of taxane neoadjuvant and/or adjuvant treatment Recurrence/metastasis interval ≥ 12 months;
- •Sufficient organ function;
- •The Eastern Cooperative Oncology Group (ECOG) score of physical status is 0-1;
- •Expected survival period ≥ 12 weeks;
- •According to the RECIST1.1 standard, the subject has at least one measurable tumor lesion.
排除标准
- •History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug;
- •Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF;
- •There is meningeal metastasis, uncontrollable or symptomatic central nervous system (CNS) metastasis;
- •Those who have active infection and currently need intravenous anti-infection treatment;
- •At present, there are uncontrollable pleural effusion, pericardium effusion and abdominal effusion;
- •Before the start of the study and treatment, fever of unknown cause > 38.5°C (according to the researcher's judgment, fever caused by tumor can be included in the group);
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Known history of alcohol abuse, psychotropic substance abuse or drug abuse;
- •Have a clear history of neurological or mental disorders, such as epilepsy, dementia and schizophrenia;
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);
- •Syphilis nonspecific antibody test is positive (such as TRUST and PRP) or syphilis specific antibody test is positive (such as TPPA) [it is acceptable that "Syphilis specific antibody test" is positive but "Syphilis nonspecific antibody test" is negative for more than one year];
- •Active tuberculosis, or a history of tuberculosis infection in the past but failed to control after treatment;
- •Active hepatitis B (HBsAg positive and HBV-DNA ≥1 1000 IU/ml) can be controlled by antiviral drugs (HBV-DNA < 1000 IU/ml). Active hepatitis C (HCV-RNA > detection limit of research center);
- •According to the researcher's judgment, the subject's basic illness may increase the risk of receiving the study drug, or confuse the explanation of the toxic reaction and AE;
- •It is expected that any other form of anti-tumor drug treatment will be required during the study;
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
PM8002+nab-paclitaxel
PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th days of each cycle until unacceptable toxicity or disease progression were observed. Each cycle contains 28 days.
干预措施: PM8002 (Drug)
PM8002+nab-paclitaxel
PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th days of each cycle until unacceptable toxicity or disease progression were observed. Each cycle contains 28 days.
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Objective Response Rate
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
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
次要结局
- Disease control rate (DCR)(Up to approximately 2 years)
- Duration of response (DoR)(Up to approximately 2 years)
- Progression free survival (PFS)(: Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)