JPRN-jRCT2031220588招募中1 期
A PHASE I OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SAIL66 IN PATIENTS WITH CLDN6-POSITIVE LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Jane Royalty0 个研究点目标入组 178 人开始时间: 2023年1月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 178
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
- >= 18age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Age >= 18 years at time of signing Informed Consent Form
- •Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
- •Patients with CLDN6 positive solid tumors
排除标准
- •Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, whichever is longer
- •Primary central nervous system (CNS) malignancy, symptomatic (seizures etc.) CNS metastases, actively progressing CNS metastases or CNS metastases required any anti-cancer treatment
- •History or presence of CNS disease such as stroke (e.g., subarachnoid hemorrhage or cerebral infarction), epilepsy, CNS vasculitis, neurodegenerative disease, aphasia, dementia or paresis
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites
研究者
相似试验
招募中
不适用
AN OPEN-LABEL, MULTICENTER, PHASE I STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND PRELIMINARY CLINICAL ACTIVITY OF RO7428731 IN PARTICIPANTS WITH GLIOBLASTOMA EXPRESSING MUTANT EPIDERMAL GROWTH FACTOR RECEPTOR VARIANT IIIOncologie: GlioblastomahersentumorGlioblastomaNL-OMON54263Roche Nederland B.V.35
招募中
1 期
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants With ALK Fusion-Positive Solid or CNS TumorsALK fusion-positive extracranial solid or primary CNS tumors who have progressed following prior treatment or who have no satisfactory treatment availableMedDRA version: 20.0Level: LLTClassification code: 10025648Term: Malignant mast cell tumors unspecified site extranodal and solid organ sites Class: 10029104CTIS2023-504084-17-00F. Hoffmann-La Roche AG55
进行中(未招募)
1 期
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants with Anaplastic Lymphoma Kinase (ALK) Fusion-Positive Solid or Central Nervous System (CNS) TumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)ALK fusion-positive extracranial solid or primary CNS tumors who have progressed following prior treatment or who have no satisfactory treatment availableMedDRA version: 21.0Level: LLTClassification code 10028992Term: Neoplasm CNSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-004239-25-DEF. Hoffmann-La Roche Ltd42
进行中(未招募)
1 期
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Participants with Anaplastic Lymphoma Kinase (ALK) Fusion-Positive Solid or Central Nervous System (CNS) TumorsALK fusion-positive extracranial solid or primary CNS tumors who have progressed following prior treatment or who have no satisfactory treatment availableMedDRA version: 21.0Level: LLTClassification code 10028992Term: Neoplasm CNSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-004239-25-DKF. Hoffmann-La Roche Ltd42
进行中(未招募)
1 期
A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Patients with Anaplastic Lymphoma Kinase (ALK) Fusion-Positive Solid or Central Nervous System (CNS) TumorsALK fusion-positive extracranial solid or primary CNS tumors who have progressed following prior treatment or who have no satisfactory treatment availableMedDRA version: 21.0Level: LLTClassification code 10028992Term: Neoplasm CNSSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2020-004239-25-FRF. Hoffmann-La Roche Ltd42
