EUCTR2019-003914-15-PT进行中（未招募）1 期
Open-label, single-arm trial to evaluate antitumor activity, safety, and pharmacokinetics of SAR408701 used in combination with ramucirumab in metastatic, non-squamous, non–small-cell lung cancer (NSQ NSCLC) patients with CEACAM5-positive tumors, previously treated with platinum-based chemotherapy and an immune checkpoint inhibitor - CARMEN-LC04
Sanofi-Aventis Research and Development0 个研究点目标入组 45 人开始时间: 2020年3月25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
- 45
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
- •Metastatic disease progression fulfilling both of the following 2 criteria:
- •a) Having progressive disease during or after platinum-based chemotherapy (at least 2 cycles). Maintenance therapy following platinum-based chemotherapy is not considered as a separate regimen. Adjuvant/neoadjuvant treatment for a patient who had a relapse with metastatic disease during or within 6 months of completing treatment will be considered as first-line treatment.
- •b) Having progressive disease during or after 1 immune checkpoint inhibitor (anti-PD1/PD-L1); this could be given as monotherapy or in combination with platinum-based chemotherapy (whatever the order).
- •Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of =2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50 % of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).
- •At least one measurable lesion by RECIST v1.1.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- •A female participant who agrees to use effective contraceptive methods during and for at least 7 months after the last dose of study intervention.
- •A male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of study intervention
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Patients with untreated brain metastases and history of leptomeningeal disease.
- •Significant concomitant illnesses that would impair the patient’s participation in the study or interpretation of the results.
- •History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- •Non-resolution of any prior treatment related toxicity to < grade 2 according to NCI CTCAE V5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy
- •History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis
- •Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
- •Radiographic evidence of major airway or blood vessel invasion or intratumor cavitation
- •History of uncontrolled hereditary or acquired thrombotic disorder or history of aneurism.
- •Major surgery within 28 days prior to Day 1/first IMP infusion,. Postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months.
- •History of gross hemoptysis within 2 months before the first administration of study intervention.
- •Clinically relevant congestive heart failure (CHF; NYHA II-IV or LVEF less than 50%) or symptomatic or poorly controlled cardiac arrhythmia.
- •Any arterial thrombotic event within 6 months before the first administration of study intervention.
- •Uncontrolled arterial hypertension (systolic =150 mmHg or diastolic =90 mmHg) despite standard medical management.
- •Serious or nonhealing wound, skin ulcer, or bone fracture within 28 days before the first administration of study intervention.
- •Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to first administration of study intervention.
- •Significant bleeding disorders, vasculitis, or Grade 3-4 gastrointestinal (GI) bleeding within 3 months before the first administration of study intervention.
- •Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea.
- •Medical condition requiring concomitant administration of a medication with a narrow therapeutic window and metabolized by CYP450 or a strong CYP3A inhibitor
- •Concurrent treatment with any other anticancer therapy
- •No more than 1-line previous chemotherapy in metastatic setting
- •Prior treatment with ramucirumab or docetaxel
- •Prior therapy targeting CEACAM5 or maytansinoid treatment (DM1 or DM4 antibody-drug conjugate)
- •Contraindication to use of corticosteroid premedication
- •Current therapeutic anticoagulation with warfarin, low-molecular-weight heparin, or similar agents. Patients receiving prophylactic, low-dose anticoagulation therapy are eligible
- •Previous enrollment in this study, current participation in any other clinical study involving an investigational study treatment, or any other type of medical research
- •Poor bone marrow, liver or kidney functions
- •Urine dipstick or routine analysis indicating proteinuria of 2+ or higher, unless a 24 hour urine collection demonstrates
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