EUCTR2021-002181-41-NL进行中（未招募）1 期
A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with advanced and metastatic gastrointestinal cancer (Pegasus Gastrointestinal 203)
Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 350 人开始时间: 2021年10月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
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
- •Participant must be =18 years of age (or country's legal age of majority if >18 years), at the time of signing the informed consent.
- •Participants with:
- •- Sub-study01: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic esophageal cancer of the squamous cell carcinoma subtype
- •- Sub-study02: Histologically or cytologically confirmed diagnosis of advanced unresectable or metastatic GC or Siewert Type 2 & 3 GEJ.
- •Participants (all sub-studies) must have at least one measurable lesion
- •Mandatory baseline biopsy for the first 20 participants to enroll in sub-study01 and sub-study02 .
- •Females are eligible to participate if they are not pregnant or breastfeeding, not a woman of childbearing potential (WOCBP) or are a WOCBP that agrees:
- •- to use approved contraception method and submit to regular pregnancy testing prior to treatment and for at least 180 days after discontinuing study treatment
- •- and to refrain from donating or cryopreserving eggs for 180 days after discontinuing study treatment.
- •Males are eligible to participate if they agree to refrain from donating or cryopreserving sperm, and either abstain from heterosexual intercourse OR use approved contraception during study treatment and for at least 210 days after discontinuing study treatment.
- •Capable of giving signed informed consent
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 210
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Eastern Cooperative Oncology Group (ECOG) performance status of =2
- •- Poor organ function
- •- Active brain metastases or leptomeningeal disease.
- •- History of allogenic or solid organ transplant.
- •- Last administration of prior antitumor therapy or any investigational treatment within 28 days or less than 5 times the half-life, whichever is shorter; major surgery within 28 days prior to first IMP administration
- •- Comorbidity requiring corticosteroid therapy
- •- Antibiotic use (excluding topical antibiotics) =14 days prior to first dose of IMP
- •- Severe or unstable cardiac condition within 6 months prior to starting study treatment
- •- Active, known, or suspected autoimmune disease that has required systemic treatment in the past 2 years
- •- Participants with baseline SpO2 =92% (without oxygen therapy).
- •- Participant has received prior IL2-based anticancer treatment.
- •- Participants on sub-study02 cohort B1 and B2 or sub-study 04 – cohort D1 with prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- •- Receipt of a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
研究者
相似试验
进行中（未招募）
1 期
A study of SAR444245 combined with other anticancer therapies for the treatment of participants with HNSCC (Master Protocol)Squamous cell carcinoma of head and neckMedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-002105-99-DESanofi-Aventis Recherche & Développement228
已完成
2 期
A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with head and neck squamous cell carcinoma (HNSCC) (Pegasus Head and Neck 204)head and neck10027655cancerNL-OMON52068Genzyme Europe BV7
已完成
2 期
A Phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants with advanced and metastatic gastrointestinal cancergastrointestinal cancer10017991NL-OMON52360Genzyme Europe BV25
进行中（未招募）
1 期
A study of SAR444245 combined with other anticancer therapies for the treatment of participants with HNSCC (Master Protocol)Squamous cell carcinoma of head and neckMedDRA version: 21.0Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-002105-99-NLSanofi-Aventis Recherche & Développement228
进行中（未招募）
1 期
A study of SAR444245 combined with other anticancer therapies for the treatment of participants with lung cancer or mesotheliomaEUCTR2020-005331-78-ITSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT360