EUCTR2020-003096-18-NL进行中（未招募）1 期
Open-label, multi-cohort, Phase 2 trial, evaluating the efficacy and safety of tusamitamab ravtansine (SAR408701) monotherapy and in combination in patients with CEACAM5-positive advanced solid tumors - CARMEN-BT01
Sanofi aventis recherche & développement0 个研究点目标入组 118 人开始时间: 2020年12月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 118
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 at least 18 years of age
- •Participants with at least one measurable lesion according to the RECIST v1.1 criteria that has not been irradiated (ie, newly arising lesions in previously irradiated areas are accepted).
- •Participants with ECOG performance status 0 to 1.
- •Evidence of metastatic disease.
- •Expression of CEACAM 5 by centrally assessed IHC assay.
- •Male and female participants willing to comply with contraceptive use consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Cohort A: mBC
- •- Histological or cytologic diagnosis of breast cancer.
- •- Have received at least 2 prior cytotoxic chemotherapy regimens for non-TNBC tumor type or at least 1 for TNBC tumor type but not more than 4 in the locally recurrent or metastatic setting.
- •Cohorts B and C: mPAC
- •- Have confirmed diagnosis of pancreatic ductal adenocarcinoma.
- •Cohort B: mPAC
- •- Have documented radiographic progression or documented intolerance after at least 1 prior systemic chemotherapy line which included either gemcitabine (or relapsed within 6 months of completion of gemcitabine adjuvant therapy) or a 5-fluorouracil based regimen (including capecitabine) but no more than 2 prior chemotherapy lines for locally advanced/metastatic disease.
- •Cohort C: mPAC
- •- Have documented radiographic progression or documented intolerance after 1st line fluoropyrimidine-containing chemotherapy (or relapsed within 6 months of completion of chemotherapy as adjuvant therapy) for locally advanced/metastatic disease.
- •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 74
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Medical condition requiring concomitant administration of a medication with a narrow therapeutic window, that is metabolized by cytochrome P450 (CYP450), and for which a dose reduction cannot be considered.
- •- Medical conditions requiring concomitant administration of strong CYP3A inhibitor, unless it can be discontinued at least 2 weeks before the first administration of study intervention.
- •- Life expectancy less than 3 months.
- •- Untreated brain metastases or history of leptomeningeal disease.
- •- Significant concomitant illness
- •- 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.
- •- History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or active hepatitis A, B or C infection.
- •- Non-resolution of any prior treatment-related toxicity to - Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy.
- •- Use of contact lenses. Participants using contact lenses who are not willing to stop wearing them for the duration of the study intervention are excluded.
- •- Concurrent treatment with any other anti cancer therapy.
- •- Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for prior antitumor therapy (chemotherapy, targeted agents, immunotherapy and radiotherapy, or any investigational treatment).
- •- Any prior therapy targeting CEACAM5.
- •- Prior maytansinoid DM4 treatment (ADC).
- •- Any major surgery within the preceding 2 weeks of the first study intervention administration.
- •- Previous enrollment in this study or current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
- •- Poor renal function
- •- Poor hepatic function
- •- Poor bone marrow function
- •Cohort C: mPAC
- •- Any previous systemic therapy with taxane or gemcitabine (for Cohort C only).
- •The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
研究者
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