EUCTR2021-000441-41-NL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 300 人开始时间: 2021年5月27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
- 300
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
- •Parts A and A-2 are not conducted in EU/EEA and, therefore, specific inclusion criteria are not described.
- •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 NSCLC
- •o Patients with 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
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
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.
- •Parts A and A-2 are not conducted in EU/EEA and, therefore, specific exclusion criteria are not described.
- •Cohort B1 and B7:
- •o Treatment other than anti-PD-1 and/or chemotherapy 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 systemic drug therapy 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
研究者
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