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    Association details:
    Biomarker:CEACAM5 expression
    Cancer:Solid Tumor
    Drug:tusamitamab ravtansine (SAR408701) (Microtubule inhibitor, CEACAM5-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    SAR408701 in combination with pembrolizumab and pembrolizumab alone in patients with non-squamous non-small cell lung cancer (NSQ NSCLC) A pembrolizumabbal kombinált SAR408701 és a pembrolizumab monoterápia összehasonlítása nem laphámsejtes, nem kissejtes tüdődaganatban szenvedő betegeknél (NSQ NSCLC)

    Excerpt:
    ...-A CEACAM5 expressziója, amelyet prospektív módon bemutattak egy ≥2 + intenzitású, központilag értékelt IHC-teszttel, a tumorsejtpopuláció legalább 50%-ánál az archív tumormintában (vagy ha ez nem áll rendelkezésre, akkor friss biopsziás mintán). ...
    Trial ID:
    2020-000035-50
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Evaluation of SAR408701 in Patients With Advanced Solid Tumors

    Excerpt:
    ...Patient must consent to a baseline biopsy for retrospective confirmation of tumor CEACAM5 expression, except if NSCLC or SCLC without lesion amenable to biopsy....
    Trial ID:
    CEACAM5
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

    Excerpt:
    ...- Expression of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) will be assessed centrally using the most recent archival tumor tissue (or, if...
    Trial ID:
    TusaRav-QT
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

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

    Excerpt:
    ...- 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)....
    Trial ID:
    CARMEN-LC06
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    INTRUSION: Unraveling the INTRatUmoral PK/PD relatION for SAR408701

    Excerpt:
    ...Intratumoral tusamitamab ravtansine concentration`Incidence of grade 3 or 4 adverse events`Response to treatment`CEACAM5 expression`RNA expression levels`circulating CEA levels`tumor genomic features`Maximal plasma concentration`AUCinf`AUClast`AUCt`Thalf`systemic tusamitamab ravtansine concentration`Volume of distribution`concentration DM4 metabolites: Lys-SPDB-DM4, Me-Dm4`features in tumor micro-environment...
    Trial ID:
    INTRUSION
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors

    Excerpt:
    ...- At least 6 x 5 μm slides from formalin-fixed paraffin-embedded (FFPE) archival tissue should be available for retrospective central evaluation of CEACAM5 expression....
    Trial ID:
    NCT03324113
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrialsregister.eu
    Title:

    Tusamitamab ravtansine in NSQ NSCLC participants with negative or moderate CEACAM5 expression tumors and high circulating CEA

    Excerpt:
    ...- 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). ...
    Trial ID:
    2021-004423-32
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer Res Commun
    Title:

    Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens

    Published date:
    08/28/2023
    Excerpt:
    Adults ages ≥18 years (range, 34-73) with locally advanced/metastatic solid tumors (N = 43...expressing/likely to express CEACAM5 received intravenous tusamitamab ravtansine...stable disease occurred in 35.7% of patients in Q2W-LD and 40.0% of patients in Q3W.
    DOI:
    10.1158/2767-9764.CRC-23-0284
    Trial ID:
    CEACAM5