EUCTR2021-000441-41-DE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 405 人开始时间: 2022年4月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 405
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Part A is not conducted in EU/EEA and, therefore, specific inclusion criteria are not described.
- •Part A-2: : Patients with any previously treated solid tumor-type other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma, confirmed by available pathology records and/or current biopsy, that is advanced (non-resectable or metastatic), or recurrent and progressing since last anti-tumor therapy, and for which no alternative, standard therapy exists.
- •Patients with Non-small Cell Lung Cancer (NSCLC) or other protocol-specified solid tumors with locally advanced or metastatic, non-resectable disease, which has progressed despite treatment with first-line standard-of-care treatment, or first- and second-line treatment, dependent on expansion cohort.
- •Prior therapy must have been completed 2-4 weeks prior to the administration of the first dose of study drug as specified per protocol according to type of prior therapy.
- •Part B: (all cohorts): Patients with locally advanced or metastatic, nonresectable disease per cohort specific criteria listed in the protocol:
- •Cohorts B1, B3 and B7
- •o Patients with locally advanced or metastatic, non-resectable NSCLC and documented PD-L1 expression on =50% of tumor cells# (Cohort B1, B3) or documented PD-L1 expression on =1%-49% of tumor cells # (Cohort B7)
- •o Patients must have received at least 1, and a maximum of 3, previous
- •lines of therapy, including at least 1 previous line containing a PD-(L)1
- •checkpoint inhibitor (Cohort B1, B7)
- •For patients enrolled to Cohorts B1 and B7 in Germany, they must have received both an anti-PD-(L)1 therapy and a platinum-based chemotherapy (i.e., at least 2 prior lines of treatment) to be eligible for study entry.
- •o Patients with locally advanced or metastatic, non-resectable HPV-associated (i.e. HPV+ tumor) SCC of the anus, cervix, vulva, vagina, penis or oropharynx
- •o Patients with recurrent, persistent or metastatic ovarian, primary peritoneal or fallopian tumor carcinoma
- •o Patients with head and neck squamous cell cancer
- •Cohort B6:
- •o Patients with measureable TNBC
- •Cohort B8
- •o Patients with metastatic, non-resectable colorectal cancer (mCRC) that is MSS or MSI low
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •Previous immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients.
- •Active or prior autoimmune disease, with the following allowed exceptions:
- •o Vitiligo, autoimmune thyroiditis, or psoriasis (not requiring systemic treatment within 2 years), type I diabetes on stable insulin therapy or – in the view of the Investigator – resolved childhood asthma/atopy;
- •o Intermittent use of bronchodilators, inhaled steroids or local steroid injections including intra-articular injections;
- •o Hypothyroidism stabilized on HRT; and
- •o Celiac disease adequately controlled by diet alone.
- •Part A2: 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.
- •Cohort B1 and B7:
- •o Treatment with any PD-L1-directed therapy within 5 (five) half-lives of the respective drug; if the half-life of the respective PD-L1 antibody is unknown, treatment with such a PD-L1 antibody within 12 weeks prior to the first dose of study drug is exclusionary.
- •o Previous treatment with a PD-(L)1x4-1BB specific antibody or any other treatment targeting 4-1BB
- •o Treatment other than anti-PD-(L)1 or chemotherapy within 28 days prior to treatment initiation or not recovered to CTCAE V5.0 Grade 1 or better from AE due to prior anti-PD-1 administration
- •Cohort B2:
- •o Treatment other than anti-PD-1 or a platinum-based chemotherapy regimen recommended as first-line or second-line treatment by current NCCN treatment guidelines or not recovered to CTCAE V5.0 Grade 1 or better from AE due to first- or second-line treatment.
- •Cohort B3:
- •o Any treatment other than a local standard-of-care first-line chemotherapy regimen or not recovered to CTCAE V5.0 Grade 1 or better from AE due to first-line treatment.
- •o Receipt of a PD-1, PD-L1, 4-1BB or CTLA-4 antibody or any other investigational biological drugs.
- •o EGFR tyrosine kinase activating mutations or ALK gene rearrangements.
- •Cohort B4:
- •o Prior therapy with anti-PD-1, anti-PD-L1, anti-4-1BB or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways.
- •o Prior chemotherapy for any abdominal or pelvic tumor other than ovarian, fallopian tube, or primary peritoneal cancer within 3 years
- •Cohort B5:
- •o Previous checkpoint inhibitor for their disease.
- •Cohort B6:
- •o For subgroup 1:
- •-Treatment with PD-1 or PD-L1 antibody within 2 weeks or 5 half-lives of first dose of study drug, respectively.
- •-Has not recovered to CTCAE V5.0 Grade 1 or better from AE due to prior anti-PD-1 or anti-PD-1 antibody.
- •-Previous treatment with anti-CTLA-4 or anti-4-1BB antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways other than the PD-1/PD-L1 pathway
- •o For subgroup 2:
- •-Prior therapy with anti-PD-1, anti-PD-L1, anti-4-1BB or anti-CTLA-4 antibodies or any other antibody or drug specifically targeting T-cell co-stimulation or immune check point pathways
- •Cohort B8:
- •o Patients who have previously been treated with trifluridine/tipiracil or
- •regorafenib;
- •o Patients who have previously been treated with T-cell bispecifics, 4-1BB agonists, or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD1
- •o Patients who have received treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) prior initiation of study treatment
研究者
相似试验
进行中（未招募）
1 期
A Study of NM21-1480 in Adult Patients With Advanced Solid TumorsEUCTR2021-000441-41-ESumab Therapeutics AG167
进行中（未招募）
1 期
A Study of NM21-1480 in Adult Patients With Advanced Solid TumorsEUCTR2021-000441-41-NLumab Therapeutics AG300
撤回
不适用
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.cancerNL-OMON52041umab Therapeutics20
终止
1 期
A Study of NM21-1480 in Adult Patients With Advanced Solid TumorsAdvanced Solid TumorOvarian CarcinomaFallopian Tube CancerHead and Neck Squamous Cell CarcinomaTriple Negative Breast CancerColorectal CancerNon-small Cell Lung CancerSquamous Cell CarcinomaPeritoneal CarcinomaNCT04442126Numab Therapeutics AG52
已完成
2 期
A phase II study of the anti-PDL1 antibody atezolizumab, bevacizumab and acetylsalicylic acid to investigate safety and efficacy of this combination in recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal adenocarcinomaNL-OMON50342Radboud Universitair Medisch Centrum38