A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2/B7-H7
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 131
- 试验地点
- 7
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
NPX267 is an antibody drug targeting the inhibitory receptor for B7-H7 (HHLA2) which may control evasion of the immune response in tumors. The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer. The main questions it aims to answer are:
- what is an appropriate dose to be given to patients?
- are the side effects of treatment manageable?
Participants will be evaluated for participation in the study. Patients who are treated will receive an intravenous infusion of NPX267 every three weeks if their disease has not progressed. Patients will be closely monitored by the treating physician.
详细描述
This trial is divided into two parts. The first part (dose escalation) will test different doses of drug to find a dose for part two. In the second part (dose expansion), more patients will be tested to see if the drug has an effect on patient's tumors.
Throughout the study, data will be collected to characterize the clinical activity of the drug. Samples of blood will be taken to help in an understanding of how the drug behaves in the body by assessing the amount of drug in the blood over time (pharmacokinetics), and changes in blood components (pharmacodynamics and safety). Tumor imaging by computed tomography (CT) or magnetic resonance imaging (MRI) will be done about every nine weeks to assess NPX267 impact on tumor growth.
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
- 否
入选标准
- •Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to standard of care therapy in one of the following indications: Part 1a: non-small cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), cholangiocarcinoma (CCA), pancreatic cancer (PDAC), urothelial carcinoma (UCC), gastric/gastroesophageal carcinoma, triple negative breast carcinoma, endometrial carcinoma, cervical cancer, osteosarcoma, and prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Normal bone marrow, kidney and liver function
- •Willing to use highly effective contraceptive measures throughout the trial
排除标准
- •Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia, chronic neuropathy > 6 months, or changes in skin pigmentation
- •Have known or suspected brain metastases, unless they are clinically stable
- •Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily
- •History of grade 3 immune-related pneumonitis or colitis
研究组 & 干预措施
NPX267 Treatment
干预措施: NPX267 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: up to 12 weeks from first dose
Number and type of adverse events categorized by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Number of subjects with tumor response in tumors expressing B7-H7/HHLA2
时间窗: up to 12 weeks from first dose
The proportion of subjects with complete or partial responses or stable disease as defined by RECIST 1.1 criteria
Incidence of dose limiting toxicity
时间窗: from first dose through 21 days
Number of subjects with dose limiting toxicity
次要结局
- Overall survival(From first dose until death from any cause through 30 months)
- Area under the concentration curve (AUC) of NPX267(Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles))
- Immunogenicity of NPX267(From first dose through one year)
- Maximum plasma concentration (Cmax) of NPX267(Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles))
- Half-life in circulation (T1/2) of NPX267(Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles))