NL-OMON51893已完成2 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 - ACT16432 Carmen-BT01
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
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
- •- Participant must be at least 18 years of age.
- •- Participants with at least one measurable lesion according to the RECIST 1.1
- •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 CEACAM5 by centrally assessed IHC assay.
- •- 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.
- •- Have confirmed diagnosis of pancreatic ductal adenocarcinoma.
- •- 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.
- •- Have confirmed diagnosis of pancreatic ductal adenocarcinoma.
- •- Have documented radiographic progression or documented intolerance after 1st
- •fluoropyrimidine-containing chemotherapy (or relapsed within 6 months of
- •completion of
- •chemotherapy as adjuvant therapy) for locally advanced/metastatic disease.
- •- Contraceptive use by men or women should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •- Capable of giving signed informed consent.
排除标准
- •Medical Condition
- •- 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 to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active
- •thyroiditis controlled with hormone replacement therapy (HRT).
- •- 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.
- •Prior/Concomitant therapy
- •- Concurrent treatment with any other anti-cancer therapy.
- •- Washout period before the first administration of study intervention of less
- •than 3 weeks of 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 3 weeks of the first study
- •intervention administration.
- •- Any previous systemic therapy with taxane or gemcitabine (for Cohort C only).
- •Prior/concurrent clinical study experience
- •- 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.
- •Diagnostic assessments
- •- Poor renal function.
- •- Poor hepatic function.
- •- Poor bone marrow function.
研究者
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