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BIOMARKER:

CEACAM5 overexpression

i
Other names: CEACAM5, CEA Cell Adhesion Molecule 5, Carcinoembryonic Antigen-Related Cell Adhesion Molecule 5, Meconium Antigen 100, CD66e, Carcinoembryonic Antigen, CD66e Antigen
Entrez ID:
Related biomarkers:
16d
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=80, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jul 2025 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
1m
Enrollment open
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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CEACAM5 expression • CEACAM5 overexpression
|
cyclophosphamide • fludarabine IV • Undisclosed anti-CEA-CAR-T
4ms
Enrollment closed
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
7ms
New P1 trial • CAR T-Cell Therapy • Metastases
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
cyclophosphamide • fludarabine IV • Undisclosed anti-CEA-CAR-T
8ms
Tusamitamab ravtansine plus ramucirumab as 2L therapy or beyond in patients with metastatic NSq NSCLC and high CEACAM5 expression (CARMEN-LC04) (ESMO 2023)
Docetaxel ± ramucirumab (ram) every 3 weeks is standard second-line therapy for mNSQ NSCLC without targetable mutations after progression on immunotherapy ± chemotherapy. Conclusions Tusa rav + ram showed encouraging efficacy. The safety of this combination was consistent with the safety profile of each drug, with no unexpected safety signals.
Clinical • IO biomarker • Metastases
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
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EGFR mutation • BRAF mutation • CEACAM5 expression • CEACAM5 overexpression
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docetaxel • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
9ms
Immuno-PET of colorectal cancer with a CEA-targeted [68 Ga]Ga-nanobody: from bench to bedside. (PubMed, Eur J Nucl Med Mol Imaging)
[68 Ga]Ga-HNI01 is a novel CEA-targeted PET imaging radiotracer with excellent pharmacokinetics and favorable dosimetry profiles. [68 Ga]Ga-HNI01 PET is an effective and convenient imaging tool for detecting CRC lesions, particularly for identifying small metastases. Furthermore, its high specificity for CEA in vivo makes it an ideal tool for selecting patients for anti-CEA therapy.
Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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CEACAM5 expression • CEACAM5 overexpression
1year
Tumor Growth Suppression of Pancreatic Cancer Orthotopic Xenograft Model by CEA-Targeting CAR-T Cells. (PubMed, Cancers (Basel))
Thus, the therapeutic effect of CAR-T therapy was related to the target antigen expression level, and the further retrospective analysis of pathological findings from PDAC patients showed a correlation between the intensity of CEA immunostaining and tumor heterogeneity. Therefore, CEA expression levels in biopsies or surgical specimens can be clinically used as biomarkers to select PDAC patients for anti-CAR-T therapy.
Preclinical • Journal • CAR T-Cell Therapy • IO biomarker
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
over1year
An NGS assay to identify HLA loss of heterozygosity for future CEA and MSLN logic-gated CAR-T solid tumor protocols designed for reduced on-target, off-tumor toxicity (SITC 2022)
6 Tempus xT-Onco reliably detects HLA LOH and quantifies CEA and MSLN expression. Based on these data, patients with solid tumors are now being prospectively screened for HLA LOH using xT-Onco in an ongoing tissue banking study (BASECAMP-1, NCT04981119 ), preparing for future interventional protocols.
Clinical • Tumor mutational burden • IO biomarker • Next-generation sequencing
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin) • CEACAM5 (CEA Cell Adhesion Molecule 5)
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MSLN expression • CEACAM5 expression • HLA-A*02 • CEACAM5 overexpression
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Tempus xT Assay
|
Solid tumor CAR-T therapy
over1year
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=80, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2024 --> Jul 2025 | Trial primary completion date: Oct 2024 --> Jul 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CEACAM5 (CEA Cell Adhesion Molecule 5) • CSF2 (Colony stimulating factor 2)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
over1year
Safety and efficacy of tusamitamab ravtansine in patients with colorectal or gastric cancer expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) (ESMO 2022)
Corneal toxicity was manageable with dose delay or modification. Conclusions Tusamitamab ravtansine was well tolerated in patients with CRC or GC.
Clinical
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
tusamitamab ravtansine (SAR408701)
over1year
CEACAM5 targeted by miR-498 promotes cell proliferation, migration and epithelial to mesenchymal transition in gastric cancer. (PubMed, Transl Oncol)
The outcomes of this research suggest that miR-498 is capable of repressing the proliferation, migration, and EMT of GC cells through CEACAM5 downregulation.
Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
almost2years
Tusamitamab Ravtansine in Patients with NSQ NSCLC and Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA (IASLC-WCLC 2022)
A Phase 3 study (NCT04154956) is currently ongoing in previously treated patients with NSQ NSCLC and high CEACAM5 expression comparing tusamitamab ravtansine to docetaxel. The study is designed to determine whether a broader patient population can benefit from treatment with tusamitamab ravtansine, compared with the patient population in the ongoing phase 3 study. Clinical Trials.gov identifier: NCT05245071.
Clinical • IO biomarker
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
docetaxel • tusamitamab ravtansine (SAR408701)
almost2years
Carbon Material Hybrid Construction on an Aptasensor for Monitoring Surgical Tumors. (PubMed, J Anal Methods Chem)
The limit of detection for CEA in PBS and serum is calculated from a linear regression graph to be 0.5 ng/mL with R values of 0.9593 and 0.9657, respectively, over a linear range from 0.5 to 500 ng/mL. This CEA quantification by the aptasensor can help diagnose various surgical tumors and monitor their progression.
Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
almost2years
Safety and efficacy of tusamitamab ravtansine (SAR408701) in long-term treated patients with nonsquamous non–small cell lung cancer (NSQ NSCLC) expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). (ASCO 2022)
Almost half (47%) of pts who achieved a PR were treated for ≥ 1 y, suggesting that response to tusa in heavily pretreated pts was durable and frequently sustained. No patient discontinued long-term treatment because of drug-related toxicity. Corneal toxicity in these pts was manageable with dose modification (delay/reduction).
Clinical • PD(L)-1 Biomarker • IO biomarker
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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CEACAM5 expression • CEACAM5 overexpression • PGR expression
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tusamitamab ravtansine (SAR408701)
almost2years
Affimer Tagged Cubosomes: Targeting of Carcinoembryonic Antigen Expressing Colorectal Cancer Cells Using In Vitro and In Vivo Models. (PubMed, ACS Appl Mater Interfaces)
Xenografts subjected to targeted drug-loaded cubosomes showed a 5-7-fold higher drug accumulation in the tumor tissue compared to the liver, kidneys, and other vital organs, a significant decrease in tumor growth, and an increased survival rate compared to the nontargeted group. This work encompasses the first thorough preclinical investigation of Affimer targeted cubosomes as a cancer therapeutic.
Preclinical • Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
2years
Open-label, phase II study of tusamitamab ravtansine (SAR408701) in combination with pembrolizumab and with pembrolizumab + platinum-based chemotherapy +/− pemetrexed in patients with CEACAM5-positive nonsquamous NSCLC (CARMEN-LC05) (ELCC 2022)
The primary objective is to assess tolerability and determine the recommended dose in the combinations in Parts A, B, and C. Key secondary objectives are safety/tolerability, antitumor activity (objective response rate), pharmacokinetics, and immunogenicity. As of Jan 5, 2022, 27 sites in 7 countries are recruiting.
Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CEACAM5 (CEA Cell Adhesion Molecule 5) • TNFRSF9 (TNF Receptor Superfamily Member 9)
|
CEACAM5 expression • CEACAM5 overexpression • CEACAM5 positive
|
Keytruda (pembrolizumab) • pemetrexed • tusamitamab ravtansine (SAR408701)
2years
CEA-Regulated Oncolytic Virus Anticancer Therapy: A Promising Strategy for Rare Solid Tumors. (PubMed, Curr Cancer Drug Targets)
Due to high tumor specificity, CEA-regulated OA therapy has demonstrated a surprising antitumor effect for common CEA-positive tumors in preclinical trials These data suggested that CEA could be a diagnostic and prognostic biomarker for several rare solid tumors. We proposed the hypothesis that CEA-regulated oncolytic virus therapy could be a promising therapeutic strategy for CEA-positive rare solid tumors.
Journal • Oncolytic virus • IO biomarker
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression • CEACAM5 positive
2years
Initial evaluation of Tc-labeled anti-CEA scFv for micro-SPECT imaging in mice with colorectal cancer. (PubMed, J Labelled Comp Radiopharm)
The micro-single photon emission computed tomography (micro-SPECT) imaging of [ Tc]Tc-scFv-96NRT showed a specific accumulation pattern, as blocking experiment with excess scFv-96NRT suppressed the tumor uptake. These preliminary results suggest that [ Tc]Tc-scFv-96NRT is a potential non-invasive molecular probe for imaging tumors with CEA over-expression.
Preclinical • Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
over2years
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=80, Recruiting, Hoffmann-La Roche | Trial completion date: Jun 2024 --> Oct 2024 | Initiation date: Apr 2021 --> Jul 2021 | Trial primary completion date: Jun 2024 --> Oct 2024
Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CEACAM5 (CEA Cell Adhesion Molecule 5) • CSF2 (Colony stimulating factor 2)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • cibisatamab (RG7802)
over2years
[VIRTUAL] Phase II single-arm trial of safety, antitumor activity, and pharmacokinetics of tusamitamab ravtansine (SAR408701) plus ramucirumab in CEACAM5-positive, metastatic, non-squamous, non-small cell lung cancer progressing on platinum-based chemotherapy and immunotherapy (ESMO 2021)
Background: In patients with metastatic non-small cell lung cancer (NSCLC) lacking targetable mutations who progress on immunotherapy and platinum-based chemotherapy, treatment options are generally limited to docetaxel ± a VEGF inhibitor such as ramucirumab. Parts 1 and 2 secondary endpoints include: safety, duration of response, progression-free survival, pharmacokinetics of tusa and ramucirumab, and anti-therapeutic antibodies. This study is recruiting participants at 12 sites in 6 countries, and has reached part 2 at all sites.
Clinical • P2 data • PK/PD data • IO biomarker
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
|
EGFR mutation • BRAF mutation • CEACAM5 expression • CEACAM5 overexpression • CEACAM5 positive
|
docetaxel • Cyramza (ramucirumab) • tusamitamab ravtansine (SAR408701)
over2years
[VIRTUAL] Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) tumor expression in a phase I/II study of tusamitamab ravtansine (SAR408701) in patients (pts) with advanced non-small cell lung cancer (NSCLC) (ESMO 2021)
Almost 20% of prescreened NSCLC pts had high CEACAM5 expression. High CEACAM5 expressors exhibited a mixed pattern of whole membrane and polarized staining, with a predominance of whole membrane expression. In CEACAM5 moderate expressors, whole membrane CEACAM5 expression was similar to polarized CEACAM5 expression.
Clinical • P1/2 data
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression • CEACAM5 positive
|
tusamitamab ravtansine (SAR408701)
almost3years
CEACAM5 overexpression is a reliable characteristic of CD133-positive colorectal cancer stem cells. (PubMed, Cancer Biomark)
High CEACAM5 expression in colorectal cancer cells is firmly associated with the CD133-positive colorectal CSC phenotype, but it is unlikely that CD133 directly regulates CEACAM5 expression.
Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5) • S100A8 (S100 Calcium Binding Protein A8) • S100A9 (S100 Calcium Binding Protein A9)
|
CEACAM5 expression • CEACAM5 overexpression • CEACAM5 positive • CD133 expression • CD133 positive • CD133 overexpression
almost3years
Clinical • New P1/2 trial • Combination therapy
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CEACAM5 (CEA Cell Adhesion Molecule 5) • CSF2 (Colony stimulating factor 2)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • cibisatamab (RG7802)
over3years
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors (clinicaltrials.gov)
P1; N=26; Terminated; Sponsor: Hoffmann-La Roche; Completed --> Terminated; Study terminated due to change in benefit-risk ratio, driven by high incidence GI toxicity in absence of clinically significant anti-tumor efficacy.
Trial termination • Clinical
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CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • RG6123
over4years
Clinical • Trial completion
|
CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • RG6123
over4years
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors (clinicaltrials.gov)
P1, N=26, Terminated, Hoffmann-La Roche | N=150 --> 26 | Trial completion date: Dec 2020 --> Jul 2019 | Recruiting --> Terminated | Trial primary completion date: Dec 2020 --> Jul 2019; Study terminated due to change in benefit-risk ratio, driven by high incidence GI toxicity in absence of clinically significant anti-tumor efficacy.
Clinical • Enrollment change • Trial completion date • Trial termination • Trial primary completion date
|
CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • RG6123
almost5years
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors (clinicaltrials.gov)
P1, N=150, Recruiting, Hoffmann-La Roche | Trial completion date: Jun 2021 --> Dec 2020
Clinical • Trial completion date
|
CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • RG6123
5years
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors (clinicaltrials.gov)
P1, N=150, Recruiting, Hoffmann-La Roche | Trial completion date: Apr 2020 --> Jun 2021 | Trial primary completion date: Oct 2019 --> Dec 2020
Clinical • Trial completion date • Trial primary completion date
|
CEACAM5 (CEA Cell Adhesion Molecule 5) • CD4 (CD4 Molecule)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • RG6123