NL-OMON52041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. - NB-ND021 (NM21-1480)-101 [ICON 5013/0001]
umab Therapeutics0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 20
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Parts A and A-2 are not conducted in EU/EEA and, therefore, specific
- •inclusion criteria are not described.
- •Part B (all cohorts): Patients with locally advanced or metastatic,
- •non-resectable disease.
- •Cohorts B1 and B7
- •o Patients with NSCLC
- •Cohort B2
- •o Patients with HPV-associated (i.e. HPV+ tumor) SCC of the anus, cervix,
- •vulva, vagina, penis or oropharynx
- •Cohort B4
- •o Patients with recurrent, persistent or metastatic ovarian, primary peritoneal
- •or fallopian tumor carcinoma
- •Cohort B5
- •o Patients with head and neck squamous cell cancer
- •Cohort B6
- •o Patients with TNBC according to current ASCO/CAP guidelines that is
- •measurable according to RECIST1.1 criteria
- •For Cohorts B1, B2, B6 (subgroup with required previous checkpoint inhibitor
- •therapy) and B7: Last dose of therapy with anti-PD-1 antibody must have been
- •received at least 2 weeks prior to the administration of the first dose of the
- •study drug. All cohorts (while not applicable to Cohort B5): Prior
- •chemotherapy must have been completed at least 4 weeks prior to the
- •administration of the first dose of study drug. Exceptions: Hormone
- •replacement therapy.
排除标准
- •Key Exclusion Criteria:
- •Patient previously had known immediate or delayed hypersensitivity reaction or
- •idiosyncrasy to the excipients of investigational product (IP) or has
- •experienced >= Grade 3 irAEs with previous checkpoint inhibitor therapy.
- •Cohort B1 and B7:
- •o Treatment with PD-1 antibody within 2 weeks.
- •o Patients 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 are acceptable.
- •Cohort B2:
- •o 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- or second-line
- •treatment; 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 disorders treated with hormone replacement are
- •acceptable.
- •Cohort B4:
- •o Patients who have had prior therapy with anti-PD-1, anti-PD-L, anti-4-1-BB or
- •anti-CTLA-4 antibodies or any other antibody or drug specifically targeting
- •T-cell co-stimulation or immune check point pathways.
- •o Patients who have received prior chemotherapy for any abdominal or pelvic
- •tumor other than for treatment of ovarian, fallopian tube, or primary
- •peritoneal cancer within the last 3 years; patients may have received prior
- •adjuvant chemotherapy and radiotherapy for localized breast cancer, provided
- •that it was completed more than 2 years prior to consenting to this study, and
- •the patient remains free of recurrent or metastatic disease and hormonal
- •therapy has been discontinued; patients who have received prior radiotherapy to
- •any portion of the abdominal cavity or pelvis or thoracic cavity within the
- •last 3 years are excluded; prior radiation for localized cancer of the head and
- •neck or skin is permitted, provided that it was completed more than 3 years
- •prior to consenting to this study, and the patient remains free of recurrent or
- •metastatic disease.
- •Cohort B5
- •o Patients who have previously received systemic drug therapy for their disease.
- •Cohort B6
- •o For patients in the subgroup in which previous therapy with a checkpoint
- •inhibitor is required:
- •* Treatment with PD-1 antibody within 2 weeks prior to the first dose of study
- •* Treatment with PD-L1 antibody within 5 half-lives prior to first dose of
- •* Patient who has not recovered to CTCAE V5.0 Grade 1 or better from the AE due
- •to anti-PD-1 or anti-PD-1 antibody administered earlier; in addition, patient
- 另有 1 项未显示
研究者
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