Open-label, Phase 2 study, evaluating the efficacy and safety of tusamitamab ravtansine in non-squamous non-small-cell lung cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating CEA - CARMEN-LC06

Sanofi Aventis Recherche & Développement0 个研究点目标入组 45 人开始时间: 2021年12月23日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•- Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
•- Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (=100 ng/mL). Moderate CEACAM5 expression is defined as intensity = 2 + in = 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
•- At least one measurable lesion by RECIST v1.1
•- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
•- Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.
•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 27
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

•- Patients with untreated brain metastases or history of leptomeningeal disease.
•- 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 uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis.
•- Significant concomitant illness that could impair the participation in the study. or interpretation of the results or any major surgery with 3 weeks prior treatment administration.
•- Nonresolution of any prior treatment-related toxicity to - Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
•- Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
•- Concurrent treatment with any other anticancer therapy
•- Poor bone marrow, liver or kidney functions.

发起方

Sanofi Aventis Recherche & Développement