Status:
TERMINATED
Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Lead Sponsor:
Sanofi
Conditions:
Non-squamous Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ N...
Detailed Description
40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 \<Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
- 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.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05245071
Start Date
June 1 2022
End Date
November 20 2024
Last Update
August 29 2025
Active Locations (35)
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1
Roswell Park Cancer Institute Site Number : 8400004
Buffalo, New York, United States, 14263
2
Renovatio Clinical Site Number : 8400003
El Paso, Texas, United States, 79915
3
Investigational Site Number : 0560003
Edegem, Belgium, 2650
4
Investigational Site Number : 0560001
Leuven, Belgium, 3000