2023-509115-84-00已完成2 期
Open-label, Phase 2 study of tusamitamab ravtansine (SAR408701) combined with pembrolizumab and tusamitamab ravtansine (SAR408701) combined with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in patients with CEACAM5-positive expression advanced/metastatic nonsquamous non-small-cell lung cancer (NSQ NSCLC)
Sanofi-Aventis Recherche & Developpement1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2024年10月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Incidence of study drug-related dose-limiting toxicity (DLTs) at Cycle 1 (C1D1 to C1D21)
研究概览
简要总结
Safety run-in part: to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population. Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): to assess the antitumor activity of several dose levels (DLs; if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically- or cytologically-confirmed diagnosis of advanced or metastatic NSQ NSCLC with no EGFR sensitizing mutation or BRAF mutation or ALK/ROS alterations.
- •No prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of advanced or metastatic disease).
- •Expression of CEACAM5 as demonstrated prospectively by a centrally assessed IHC assay of ≥2+ in intensity involving at least 1% of the tumor cell population in archival tumor sample (or if not available fresh biopsy sample).
- •Measurable disease based on RECIST 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •Life expectancy of at least 3 months.
排除标准
- •Medical condition requiring concomitant administration of a medication with a strong CYP3A inhibitor.
- •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 any investigational treatment).
- •Any prior therapy targeting CEACAM
- •Uncontrolled brain metastases and history of leptomeningeal disease.
- •Any prior treatment with any other anti-PD-1, or PD-L1 or programmed death ligand 2 (PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-
- •Any prior maytansinoid treatment (DM1 or DM4 ADC).
- •Is receiving systemic steroid therapy ≤3 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication. Daily steroid replacement therapy or any corticosteroid premedication if applicable are allowed.
- •Any radiation therapy to lung >30 Gy within 6 months of first study intervention administration.
- •Has received or will receive a live vaccine within 30 days prior to the first study intervention administration.
- •Any major surgery within the preceding 3 weeks of the first study intervention administration.
- •Current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
- •Non-resolution of any prior treatment-related toxicity to < Grade 2 according to NCI CTCAE V5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
- •Poor organ function
- •Significant concomitant illness, including any severe medical condition that, in the opinion of the investigator or Sponsor, 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.
- •History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B, or C infection.
- •History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or active hepatitis A, B, or C infection.
- •History of allogeneic tissue/solid organ transplantation.
- •Active infection requiring IV systemic therapy within 2 weeks prior to randomization or active tuberculosis.
- •Interstitial lung disease or history of pneumonitis that has required oral or IV steroids
- •Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy. The use of contact lenses is not permitted.
- •Symptomatic herpes zoster within 3 months prior to screening.
- •Significant allergies to humanized monoclonal antibodies.
- •Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- •Concurrent treatment with any other anticancer therapy.
- •Have received prior chemotherapy treatment for advanced/metastatic NSCLC.
- •The patient is a candidate for a curative treatment with either surgical resection and/or chemoradiation
结局指标
主要结局
Incidence of study drug-related dose-limiting toxicity (DLTs) at Cycle 1 (C1D1 to C1D21)
Incidence of study drug-related dose-limiting toxicity (DLTs) at Cycle 1 (C1D1 to C1D21)
Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): Objective response rate (ORR)
Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): Objective response rate (ORR)
次要结局
- Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0
- Progression-free survival (PFS)
- Disease control rate (DCR)
- Duration of response (DOR)
- ORR
- Pharmacokinetic concentrations
- Incidence of anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (1)
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