EUCTR2021-000441-41-ES进行中（未招募）1 期
A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients with Advanced Solid Tumors
umab Therapeutics AG0 个研究点目标入组 167 人开始时间: 2021年6月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 167
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
- •Part A (not conducted in EU) and A-2 (OPTIONAL - not conducted in EU):
- •Patients with any previously treated solid tumor-type other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma that is advanced, or recurrent and progressing since last anti-tumor therapy, and for which no alternative, standard therapy exists.
- •Prior chemotherapy or systemic radiotherapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug, and patient has recovered to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 Grade 1 or better from all adverse events (AEs) associated with prior therapy or surgery.
- •Patients with non-small cell lung cancer (NSCLC) and documented PD-L1 expression on =50% of tumor cells (Cohort B1), human papillomavirus (HPV)-associated squamous cell carcinoma (SCC) of the anus, cervix, vulva, vagina, penis or oropharynx with documented PD-L1 expression on at least 1% of tumor and/or immune cells in the tumor microenvironment (TME), as detected by a locally-assayed, Sponsor-approved PD-L1 test (Cohort B2) and NSCLC with PD-L1 expression on =50% of tumor cells (Cohort B3), with locally-advanced or metastatic, non-resectable disease, which has progressed despite standard-of-care first-line, or first-line and second-line, treatment as described per specific cohort.
- •For Cohort B1 and B2: Last dose of first-line therapy with anti-PD-1 monotherapy must have been received at least two weeks prior to the administration of the first dose of the study drug.
- •All Part B Cohorts: Prior chemotherapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug.
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients or has experienced = Grade 3 immune-related adverse events (irAEs) with previous CPI therapy.
- •Patient has an active autoimmune disease or a documented history of autoimmune disease.
- •Part A (not conducted in EU) and A-2 (OPTIONAL - not conducted in EU):
- •Treatment with any antibody targeting PD-1, CTLA-4, 4-1BB or PD-L1 or other investigational biological drugs within 5 half-lives of that antibody prior to the administration of the first dose of study drug (or within 8 weeks if the half-life is not known) prior to the administration of the first dose of study drug.
- •Treatment with any PD-1 antibody within 2 weeks.
- •Patient who for the treatment of the current cancer has received any other treatment than anti-PD-1 and/or chemotherapy prior to initiation of the study drug or who has not recovered to CTCAE V5.0 Grade 1 or better from the AE due to anti-PD-1 administered earlier; in addition, patients with any ongoing Grade 1 or higher AE of colitis, hepatitis, nephritis, or pneumonitis considered to be related to previous anti-PD-1 therapy is exclusionary. However, sensory neuropathy =Grade 2, alopecia and endocrine disorder treated with hormone replacement is acceptable.
- •Patients who, for the treatment of the current cancer, has received any treatment other than anti-PD-1 or a platinum-based chemotherapy regimen recommended as first-line or second-line treatment by current National Comprehensive Cancer Network (NCCN) treatment guidelines or who has not recovered to CTCAE V5.0 Grade 1 or better from the AE due first-line or second-line treatment; in addition, patients with ongoing Grade 1 or higher AE of colitis, hepatitis, nephritis, or pneumonitis considered to be related to previous anti-PD-1 therapy is exclusionary. However, sensory neuropathy =Grade 2, alopecia and endocrine disorders treated with hormonal replacement are acceptable.
- •Patients who, for the treatment of the current cancer, has received any treatment other than a local standard-of-care first-line chemotherapy regimen or who has not recovered to CTCAE V5.0 Grade 1 or better from the AE due first-line treatment. However, sensory neuropathy =Grade 2, alopecia and endocrine disorders treated with hormonal replacement are acceptable.
- •Patient has received a PD-1, PD-L1, 4-1BB or CTLA-4 antibody or any other investigational biological drugs for treatment of the current cancer.
- •Patients with pithelial rowth actor receptor (EGFR) tyrosine kinase activating mutations or anaplastic lymphoma kinase (ALK) rearrangements. Patients with EGFR inactivating mutations (e.g., exon 20) may be eligible.
研究者
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