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

NCT05245071 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: ACT17241U1111-1264-28282021-004423-32
• Study Type: interventional
• Target: 22
• Locations: 7 countries
• Sites: 35

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 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.

Conditions

Non-squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

  Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks

Secondary Outcomes (4)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

  From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks

• Progression-Free Survival (PFS)

  Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks

• Disease Control Rate (DCR)

  Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks

• Duration of Response (DOR)

  Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks

Study Arms (1)

Tusamitamab ravtansine

EXPERIMENTAL

Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).

Drug: Tusamitamab ravtansine

Interventions

Tusamitamab ravtansine DRUG

Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion

Also known as: SAR408701

Tusamitamab ravtansine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (35)

Roswell Park Cancer Institute Site Number : 8400004

Buffalo, New York, 14263, United States

Location

Renovatio Clinical Site Number : 8400003

El Paso, Texas, 79915, United States

Location

Investigational Site Number : 0560003

Edegem, 2650, Belgium

Location

Investigational Site Number : 0560001

Leuven, 3000, Belgium

Location

Investigational Site Number : 0560002

Liège, 4000, Belgium

Location

Investigational Site Number : 2500003

Bordeaux, 33076, France

Location

Investigational Site Number : 2500001

Créteil, 94010, France

Location

Investigational Site Number : 2500007

Marseille, 13015, France

Location

Investigational Site Number : 2500005

Montpellier, 34295, France

Location

Investigational Site Number : 2500002

Rennes, 35033, France

Location

Investigational Site Number : 2500006

Saint-Herblain, 44800, France

Location

Investigational Site Number : 2500008

Saint-Mandé, 94160, France

Location

Investigational Site Number : 2500009

Villejuif, 94800, France

Location

Investigational Site Number : 3800003

Ravenna, Emilia-Romagna, 48121, Italy

Location

Investigational Site Number : 3800004

Aviano (PN), Friuli Venezia Giulia, 33081, Italy

Location

Investigational Site Number : 3800001

Rozzano, Lombardy, 20089, Italy

Location

Investigational Site Number : 3800002

Milan, 20133, Italy

Location

Investigational Site Number : 3920002

Nagoya, Aichi-ken, 460-0001, Japan

Location

Investigational Site Number : 3920001

Sapporo, Hokkaido, 003-0804, Japan

Location

Investigational Site Number : 3920005

Hirakata-shi, Osaka, 573-1191, Japan

Location

Investigational Site Number : 3920003

Sunto Gun, Shizuoka, 411-8777, Japan

Location

Investigational Site Number : 7240004

Barcelona, Barcelona [Barcelona], 08028, Spain

Location

Investigational Site Number : 7240006

Barcelona, Barcelona [Barcelona], 08036, Spain

Location

Investigational Site Number : 7240001

L'Hospitalet de Llobregat, Barcelona [Barcelona], 08908, Spain

Location

Investigational Site Number : 7240008

Majadahonda, Madrid, 28222, Spain

Location

Investigational Site Number : 7240002

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Investigational Site Number : 7240009

Madrid / Madrid, Madrid, Comunidad de, 28040, Spain

Location

Investigational Site Number : 7240003

Málaga, 29010, Spain

Location

Investigational Site Number : 7240005

Seville, 41013, Spain

Location

Investigational Site Number : 7240007

Valencia, 46026, Spain

Location

Investigational Site Number : 7920002

Adana, 01120, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

Ankara, 06800, Turkey (Türkiye)

Location

Investigational Site Number : 7920003

Istanbul, 34300, Turkey (Türkiye)

Location

Investigational Site Number : 7920004

Istanbul, 34722, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

tusamitamab ravtansine

Limitations and Caveats

The study was terminated as per Sponsor decision and not related to any safety concern.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 17, 2022
• Study Start: June 1, 2022
• Primary Completion: March 6, 2024
• Study Completion: November 20, 2024
• Last Updated: August 29, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

FR (8); ES (9); TU (5); JP (4); BE (3); US (2); IT (4)