NCT05001347已完成2 期
A Phase 2 Clinical Study of TJ004309 in Combination With Atezolizumab (TECENTRIQ®) in Patients With Advanced or Metastatic Ovarian Cancers and Selected Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 15
- 主要终点
- To Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types
研究概览
简要总结
This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.
详细描述
This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors. This clinical study includes two cohorts: Cohort 1 will include Immuno-Oncology (IO) treatment naïve ovarian cancer (OC) patients who have progressed on or after platinum therapy; and Cohort 2 will include patients with head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), gastrointestinal cancer (GC), triple negative breast cancer (TNBC), or ovarian carcinoma (OC) with PD-L1 expression ≥ 1%. Additional cohorts for selected tumor types might be added later.
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
- •Cohort 1: Patients with histologically confirmed epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer subjects with any high-grade serous component, progressed on or after platinum-containing therapy and not eligible for further platinum containing treatment (platinum-resistant, platinum-refractory disease defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of receiving the last dose of platinum-based treatment).
- •Cohort 2: Patients with selected tumor types that have relapsed or progressed after 2 lines of therapy or who are ineligible for other standard of care (SOC) therapies:
- •Histologically or cytologically confirmed metastatic NSCLC
- •Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx)
- •Histologically or cytologically confirmed metastatic or non-resectable advanced metastatic gastric or gastroesophageal adenocarcinoma
- •Histologically or cytologically confirmed unresectable, locally advanced or metastatic TNBC (confirmed HER2-negative, estrogen receptor-negative and progesterone receptor-negative)
- •Histologically confirmed ovarian cancer of all high-grade epithelial types who are IO treatment naïve and have progressed after 3 months on or after platinum-containing therapy
- •PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% for NSCLC and Combined Proportion Score (CPS) ≥ 1% for all other tumor types
- •A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy
- •Patients should have no more than 5 prior lines of therapies
- •Cohort 2 - (Optional for the ovarian cohort) Pre-treatment fresh tumor biopsies and paired treatment fresh tumor biopsies will be collected from at least 5 patients. Biopsy must be excisional, incisional, or core.
排除标准
- •Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40 [Tumor necrosis factor receptor superfamily, member 4 (TNFRSF4)], CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) (only applies to ovarian cancer patients in Cohorts 1 and 2)
- •Disease progression within 3 months of starting anti-PD-1 and anti-PD-L1 inhibitors
- •Known active or chronic Hepatitis B or Hepatitis C, other hepatitides (non-alcohol steatohepatitis, alcohol or drug-related, autoimmune) serology at screening or cirrhosis
- •Active autoimmune disease requiring systemic treatment within the past 12 months
- •Active interstitial lung disease (ILD) or pneumonitis or a history of ILD
- •Brain involvement with cancer, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease; unless the lesion(s) have been radiated or resected, are considered fully treated and inactive, are asymptomatic, and no steroids have been administered for CNS disease over the 7 days prior to study treatment
- •Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
- •Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/μL with an undetectable viral load
研究组 & 干预措施
TJ004309 and Atezolizumab
Experimental
TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W
干预措施: TJ004309 (Drug)
结局指标
主要结局
To Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types
时间窗: Up to 66 weeks
Anti-tumor activity of the combination of TJ004309 and atezolizumab was measured by objective response rate (ORR) based on RECIST 1.1
次要结局
- o Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types(Up to 66 weeks)
研究者
研究点 (15)
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