EUCTR2021-004423-32-ESActive, not recruitingPhase 1
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 sites45 target enrollmentStarted: January 22, 2022Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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
Exclusion Criteria
- •- 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.
Investigators
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