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    DRUG:

    telisotuzumab adizutecan (ABBV-400)

    i
    Other names: ABBV-400, ABBV 400, ABBV400, Temab-A
    Company:
    AbbVie
    Drug class:
    Topoisomerase I inhibitor, c-MET-targeted antibody-drug conjugate
    Related drugs:
    3d
    A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination with Osimertinib as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (ChiCTR2600116886)
    P2/3, N=688, Not yet recruiting, Shanghai Chest Hospital; Shanghai Chest?Hospital
    New P2/3 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    EGFR L858R • EGFR exon 19 deletion
    |
    Tagrisso (osimertinib) • telisotuzumab adizutecan (ABBV-400) • simmitinib (SYHA1817)
    14d
    Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 (clinicaltrials.gov)
    P1, N=302, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting
    Enrollment closed • Adverse events
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    telisotuzumab adizutecan (ABBV-400) • itraconazole
    25d
    Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations (clinicaltrials.gov)
    P1/2, N=252, Recruiting, AbbVie | N=132 --> 252
    Enrollment change • Adverse events • Checkpoint inhibition
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR wild-type
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • budigalimab (ABBV-181) • telisotuzumab adizutecan (ABBV-400)
    2ms
    A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=430, Recruiting, AbbVie | Not yet recruiting --> Recruiting | Trial completion date: Aug 2031 --> Sep 2030 | Trial primary completion date: Aug 2031 --> Sep 2030
    Enrollment open • Trial completion date • Trial primary completion date • Adverse events
    |
    telisotuzumab adizutecan (ABBV-400)
    2ms
    A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan (clinicaltrials.gov)
    P2, N=125, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events
    |
    telisotuzumab adizutecan (ABBV-400)
    2ms
    M24-311: Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab (clinicaltrials.gov)
    P2, N=280, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting
    Enrollment closed • Adverse events
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • telisotuzumab adizutecan (ABBV-400)
    4ms
    A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan (clinicaltrials.gov)
    P2, N=125, Not yet recruiting, AbbVie
    New P2 trial • Adverse events
    |
    telisotuzumab adizutecan (ABBV-400)
    5ms
    A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=430, Not yet recruiting, AbbVie
    New P2/3 trial • Adverse events
    |
    telisotuzumab adizutecan (ABBV-400)
    5ms
    A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=694, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events
    |
    Tagrisso (osimertinib) • telisotuzumab adizutecan (ABBV-400)
    6ms
    A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (clinicaltrials.gov)
    P2, N=140, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events • Circulating tumor DNA
    |
    telisotuzumab adizutecan (ABBV-400)
    7ms
    AndroMETa-CRC-064: A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=460, Recruiting, AbbVie | Trial completion date: Apr 2029 --> Oct 2028 | Trial primary completion date: Apr 2029 --> Oct 2028
    Trial completion date • Trial primary completion date • Adverse events
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • telisotuzumab adizutecan (ABBV-400)
    7ms
    MET Alterations in Cancer and MET-Targeted Therapy: Detection Strategies, Treatment Efficacy, and Emerging Technologies. (PubMed, Target Oncol)
    This review summarizes the frequency of MET alterations across different cancer types and the clinical validation of MET alterations in MET-targeted therapies, offering a detailed comparison of objective response rates (ORR) for therapies including crizotinib, capmatinib, tepotinib, savolitinib, telisotuzumab vedotin, telisotuzumab adizutecan, and amivantamab. Additionally, emerging technologies such as circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) analyses have been investigated for their potential to improve MET alterations detection. This review also highlights studies that demonstrate the potential of MET ctDNA and CTC analyses to predict treatment responses and identify resistance mechanisms in MET-targeted therapies.
    Review • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression • MET expression
    |
    Xalkori (crizotinib) • Orpathys (savolitinib) • Rybrevant (amivantamab-vmjw) • Tepmetko (tepotinib) • Tabrecta (capmatinib) • Emrelis (telisotuzumab vedotin-tllv) • telisotuzumab adizutecan (ABBV-400)