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    DRUG CLASS:

    CEACAM5-targeted antibody-drug conjugate

    Related drugs:
    1d
    Biomarker analysis from a Phase 1/1b study of tusamitamab ravtansine in patients with advanced non-small cell lung cancer. (PubMed, Transl Oncol)
    In CEACAM5 HE, the ORR was greater with high versus low cCEA. Associations were observed between cCEA and cCEACAM5; IHC CEACAM5, cCEA, and cCEACAM5; IHC CEACAM5 and CEACAM5 mRNA, but not between IHC CEACAM5 and oncogenic drivers.
    P1 data • Journal
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • CEACAM5 (CEA Cell Adhesion Molecule 5)
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    tusamitamab ravtansine (SAR408701)
    2ms
    CARMEN-BT01: Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=50, Terminated, Sanofi | Completed --> Terminated; Sponsor decision, the decision is not related to any safety concern.
    Trial termination
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    gemcitabine • tusamitamab ravtansine (SAR408701)
    2ms
    Evaluation of the Safety, Pharmacokinetics, and Antitumor Activity of Tusamitamab Ravtansine in Patients With Nonsquamous NSCLC With High or Moderate Expression of Carcinoembryonic Antigen-Related Cell Adhesion Molecule 5. (PubMed, JTO Clin Res Rep)
    Corneal AEs occurred in 38.0% (35/92), typically grade 1/2, reversible, and manageable by dose modifications. Tusamitamab ravtansine demonstrated a favorable safety profile, objective responses, and antitumor activity in patients with high CEACAM5-expressing NSq NSCLC.
    PK/PD data • Journal
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    CEACAM5 (CEA Cell Adhesion Molecule 5)
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    tusamitamab ravtansine (SAR408701)
    3ms
    SGNCEA5C-001: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=494, Recruiting, Seagen, a wholly owned subsidiary of Pfizer | Trial completion date: May 2030 --> Sep 2030
    Trial completion date
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    Avastin (bevacizumab)
    4ms
    CARMEN-LC03: SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients (clinicaltrials.gov)
    P3, N=389, Active, not recruiting, Sanofi | Trial completion date: Jun 2025 --> Mar 2026
    Trial completion date
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    CEACAM5 (CEA Cell Adhesion Molecule 5)
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    docetaxel • tusamitamab ravtansine (SAR408701)
    4ms
    Precemtabart tocentecan, an anti-CEACAM5 antibody-drug conjugate, in metastatic colorectal cancer: a phase 1 trial. (PubMed, Nat Med)
    Precemtabart tocentecan (Precem-TcT, previously M9140) is an anti-CEACAM5 antibody-drug conjugate with the topoisomerase 1 inhibitor exatecan as payload...In the dose-escalation stage of the phase 1 trial of Precem-TcT (PROCEADE-CRC-01), 40 heavily pretreated patients with irinotecan-refractory metastatic CRC received Precem-TcT every 3 weeks across seven dose levels (DLs, 0.6-3.2 mg kg-1)...The dose-optimization part at the RDEs of 2.4 mg kg-1 and 2.8 mg kg-1 (both every 3 weeks) in PROCEADE-CRC-01 is ongoing. ClinicalTrials.gov identifier: NCT05464030 .
    P1 data • Journal
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    CEACAM5 (CEA Cell Adhesion Molecule 5)
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    irinotecan • precemtabart tocentecan (M9140)
    4ms
    Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) (clinicaltrials.gov)
    P1, N=200, Recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Feb 2026 --> Aug 2026 | Trial primary completion date: Feb 2026 --> Aug 2026
    Trial completion date • Trial primary completion date
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
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    Avastin (bevacizumab) • 5-fluorouracil • capecitabine • leucovorin calcium • precemtabart tocentecan (M9140)
    4ms
    Phase 1 study evaluating safety and pharmacokinetics of tusamitamab ravtansine monotherapy in Japanese patients with advanced malignant solid tumors. (PubMed, Int J Clin Oncol)
    Tusamitamab ravtansine demonstrated a tolerable safety profile at a dose of 80-170 mg/m2 in three different administration schedules in Japanese adults with metastatic solid tumors.
    P1 data • PK/PD data • Journal
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    CEACAM5 (CEA Cell Adhesion Molecule 5)
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    tusamitamab ravtansine (SAR408701)
    5ms
    Anti-CEACAM5 ADC M9140 in Chinese Participants With Solid Tumors (PROCEADE-CRC-02) (clinicaltrials.gov)
    P1, N=24, Recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Trial completion date: Aug 2026 --> May 2026
    Trial completion date
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    precemtabart tocentecan (M9140)
    5ms
    Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) (clinicaltrials.gov)
    P1/2, N=250, Recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2029 --> Jan 2028 | Trial primary completion date: Jan 2029 --> Jan 2028
    Trial completion date • Trial primary completion date • Pan tumor
    |
    precemtabart tocentecan (M9140)
    7ms
    Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors (clinicaltrials.gov)
    P1, N=285, Recruiting, Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
    New P1 trial
    7ms
    Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=285, Not yet recruiting, Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
    New P1 trial