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TerminatedPhase 2NCT05245071
Official study title

Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

Study 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 NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA). Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTusamitamab ravtansine

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 29, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?35 U.S. locations

Locations may change over time.

Who runs it?Sanofi

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Sanofi
Interventions being studied
Drug: Tusamitamab ravtansine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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 \<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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Roswell Park Cancer Institute Site Number : 8400004Buffalo, New York
  • Renovatio Clinical Site Number : 8400003El Paso, Texas
  • Investigational Site Number : 0560003Edegem
  • Investigational Site Number : 0560001Leuven
  • Investigational Site Number : 0560002Liège
  • Investigational Site Number : 2500003Bordeaux
  • Investigational Site Number : 2500001Créteil
  • Investigational Site Number : 2500007Marseille
  • Investigational Site Number : 2500005Montpellier
  • Investigational Site Number : 2500002Rennes
  • Investigational Site Number : 2500006Saint-Herblain
  • Investigational Site Number : 2500008Saint-Mandé

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 29, 2025. Always confirm current availability with the study team.

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