EUCTR2019-004953-96-BG进行中（未招募）1 期
Phase 2 Study of PD-1 Inhibitor JTX-4014 Alone and in Combination with Vopratelimab, an ICOS Agonist, in Biomarker-selected Subjects with Metastatic NSCLC After One Prior Platinum-containing Regimen
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 770
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able and willing to participate and comply with all study requirements and provide signed and dated informed consent prior to initiation of any study procedures
- •2. Histologically or cytologically confirmed diagnosis of NSCLC with evaluable or measurable disease according to RECIST v1.1 with at least
- •1 measurable lesion
- •3.Confirmed tumor RNA signature (TISVopra) score =7.9
- •4.Previously treated for locally advanced or metastatic NSCLC with 1 prior systemic antineoplastic platinum-containing regimen. Regimen should consist of chemotherapy with or without bevacizumab.5. Age of =
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •7. Predicted life expectancy of = 3 months
- •8. The following laboratory values:
- •a. Hemoglobin = 9.0 g/dL
- •b. Platelet count = 75 × 109 cells/L
- •c. Absolute neutrophil count > 1.5 × 109 and < 10 × 109 cells/L
- •d. Serum creatinine < 2 × the upper limit of normal (ULN)
- •e. Total bilirubin = ULN, unless the subject has a known diagnosis of
- •Gilbert's syndrome
- •f. Aspartate aminotransferase and alanine aminotransferase = 2.5 × ULN
- •g. Serum albumin = 75% of the lower limit of normal h. Lactate dehydrogenase = 550 U/L
- •9. If with medical history of the following, eligibility should be discussed with the Medical Monitor:
- •a. Prior biliary tract disorders (based on Medical Dictionary for Regulatory Activities [MedDRA] system organ class of Hepatobiliary disorders and MedDRA high-level terms of Obstructive bile duct disorders, Hepatic vascular disorders, and Structural and other bile duct disorders)
- •b. Portal hypertension and/or hepatic vascular disorders
- •10. For women of childbearing potential (WOCBP): negative serum pregnancy test within 72 hours prior to planned C1D1 and a negative urine or serum pregnancy test on C1D1. In addition, the WOCBP must be willing to complete a urine or serum pregnancy test prior to each dose of either study drug.
- •11. WOCBP and males whose partners are WOCBP must agree to use a highly effective method of birth control throughout their participation and for 5 months following the last study drug administration. Highly effective methods of birth control are defined as those that, alone or in combination, result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •1. Concurrent anticancer treatment or subject is expected to require any other form of antineoplastic therapy while on study, either approved or investigational
- •2. Current or past participation in a study of an investigational agent or using an investigational device in the metastatic setting
- •3. Chemotherapy < 28 days prior to planned C1D1
- •4. Prior immunotherapy including, but not limited to PD-1 or PD-L1 inhibitor mAb at any time, including JTX-4014; therapy with any mAb that specifically binds to ICOS, including vopratelimab; or chimeric antigen receptor T cell therapy
- •5.Organ transplantation, including allogenic or autologous stem cell transplantation
- •6. Use of anticancer therapies listed below in the metastatic setting
- •(allowed as prior treatment for localized disease):
- •a. Biologic therapy
- •b. Targeted therapy, with the exception of bevacizumab if administered in combination with a platinum-based chemotherapy regimen as first line treatment
- •7. Positive test for any of the following EGFR gene mutations in blood or tumor: Exon 18 G719A; Exon 18 G719C; Exon 18 G719S; Exon 19 Del; Exon 20 S768I; Exon 20 T790M; Exon 20 Ins; Exon 21 L858R; Exon 21
- •8. The following toxicity history:
- •a. Ongoing toxicity attributed to prior therapy that was Grade > 1 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
- •Exceptions: Grade > 1 toxicities that, in the opinion of the Investigator, should not exclude the subject (e.g., alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement therapy) and are approved by the Medical Monitor
- •b. History of pneumonitis or interstitial lung disease
- •c. Symptomatic ascites or pleural effusion (subjects who are clinically stable for > 3 months following treatment for these conditions [including therapeutic thoraco- or paracentesis] are eligible)
- •d. If with medical history of the following, eligibility should be discussed with the Medical Monitor: colitis, hepatitis, nephritis, skin reactions, or encephalitis.
- •9. Known severe intolerance or life-threatening hypersensitivity reactions to humanized mAbs or IV Ig preparations; any history of anaphylaxis; prior history of human anti-human antibody response; or known allergy to any of the study drugs (including their analogues or excipients [L-Histidine, mannitol, sodium chloride, or polysorbate 80])
- •10. Major surgery (excluding minor procedures, e.g., placement of vascular access, gastrointestinal/biliary stent, and biopsy) < 4 weeks prior to planned C1D1
- •11. Prior whole brain radiation
- •12. Subjects with the following should be reviewed with the Medical
- •Monitor prior to enrollment:
- •a. Brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation
- •b. Radiation (other than whole brain radiation) has been or will be administered < 21 days prior to planned C1D1
- •13. Active and clinically relevant bacterial, fungal, or viral infection, including known hepatitis B, C, or human immunodeficiency virus (testing not required)
- •14. Women who are pregnant, breastfeeding, or who plan to become pregnant/breastfeed while on study; men who plan to father children during the study
- •15. Concurrent second malignancy
- •16. An active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents at a dose of = 10 mg/da
研究者
相似试验
进行中（未招募）
1 期
A Study of JTX-4014 Alone and in Combination with Vopratelimab in Biomarker-selected Subjects with Lung Cancer that has Spread to Other Parts of the Body After One Prior Platinum-containing RegimeEUCTR2019-004953-96-SKJounce Therapeutics, Inc.75
进行中（未招募）
1 期
A Study of JTX-4014 Alone and in Combination with Vopratelimab in Biomarker-selected Subjects with Lung Cancer that has Spread to Other Parts of the Body After One Prior Platinum-containing RegimeMetastatic Non Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-004953-96-HRJounce Therapeutics, Inc.75
进行中（未招募）
1 期
A Study of JTX-4014 Alone and in Combination with Vopratelimab in Biomarker-selected Subjects with Lung Cancer that has Spread to Other Parts of the Body After One Prior Platinum-containing RegimeEUCTR2019-004953-96-HUJounce Therapeutics, Inc.75
终止
2 期
Study of PD-1 Inhibitor JTX-4014 Alone and in Combination With Vopratelimab in Biomarker-selected Subjects With Metastatic NSCLC After One Prior Platinum-containing RegimenNSCLCNCT04549025Jounce Therapeutics, Inc.69
尚未招募
2 期
Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically RemovedBreast CancerNCT06547476Guangdong Provincial People's Hospital40