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CARMEN-LC06: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05245071
Collaborator
(none)
38
Enrollment
19
Locations
1
Arm
23.7
Anticipated Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tusamitamab ravtansine
 Phase 2

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Jun 3, 2022
Anticipated Primary Completion Date :
Feb 2, 2024
Anticipated Study Completion Date :
May 24, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tusamitamab ravtansine

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
Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion
Other Names:
  • SAR408701

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) [Baseline up to approximately 9 months after last patient treated]

      Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

    Secondary Outcome Measures

    1. Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities [Baseline up to approximately 90 days after the last study treatment administration]

      Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    2. Progression-free survival (PFS) [Baseline up to approximately 9 months after last patient treated]

      PFS defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.

    3. Disease control rate (DCR) [Baseline up to approximately 9 months after last patient treated]

      DCR defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1

    4. Duration of response (DOR) [Baseline up to approximately 9 months after last patient treated]

      DOR, defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first

    5. Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine [Baseline up to approximately 30 days after the last study treatment administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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 <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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number :0560003 Edegem Belgium 2650
    2 Investigational Site Number :0560001 Leuven Belgium 3000
    3 Investigational Site Number :0560002 Liege Belgium 4000
    4 Investigational Site Number :2500003 Bordeaux France 33076
    5 Investigational Site Number :2500001 Creteil France 94010
    6 Investigational Site Number :2500006 Nantes France 44093
    7 Investigational Site Number :2500002 RENNES Cedex 09 France 35033
    8 Investigational Site Number :3800001 Rozzano Milano Italy 20089
    9 Investigational Site Number :3920002 Nagoya-shi Aichi Japan 460-0001
    10 Investigational Site Number :3920001 Sapporo-shi Hokkaido Japan 003-0804
    11 Investigational Site Number :3920003 Sunto-gun Shizuoka Japan 411-8777
    12 Investigational Site Number :7240004 Barcelona Barcelona [Barcelona] Spain 08028
    13 Investigational Site Number :7240006 Barcelona Barcelona [Barcelona] Spain 08036
    14 Investigational Site Number :7240002 Madrid Madrid, Comunidad De Spain 28041
    15 Investigational Site Number :7240001 Hospitalet de Llobregat Spain 08908
    16 Investigational Site Number :7240003 Málaga Spain 29010
    17 Investigational Site Number :7240005 Sevilla Spain 41013
    18 Investigational Site Number :7920003 Istanbul Turkey 34300
    19 Investigational Site Number :7920001 Malatya Turkey

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT05245071
    Other Study ID Numbers:
    • ACT17241
    • U1111-1264-2828
    • 2021-004423-32
    First Posted:
    Feb 17, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 3, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Maytansine

    Study Results

    No Results Posted as of Aug 4, 2022