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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:
    4d
    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=854, Recruiting, AbbVie | Trial completion date: Nov 2036 --> Dec 2031 | Trial primary completion date: Nov 2036 --> Dec 2031
    Trial completion date • Trial primary completion date • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • telisotuzumab adizutecan (ABBV-400)
    4d
    Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan (clinicaltrials.gov)
    P1, N=694, Recruiting, AbbVie | N=512 --> 694 | Trial primary completion date: Jul 2026 --> Jul 2027
    Enrollment change • Trial primary completion date • Adverse events • First-in-human
    |
    PD-1 (Programmed cell death 1)
    |
    BRAF V600E • BRAF V600 • HER-2 mutation
    |
    Avastin (bevacizumab) • budigalimab (ABBV-181) • telisotuzumab adizutecan (ABBV-400)
    7d
    Telisotuzumab Adizutecan (ABBV-400), a Novel c-Met-Targeting Antibody-Drug Conjugate: First-in-Human Results in Advanced Gastric/Gastroesophageal Junction Cancer. (PubMed, Clin Cancer Res)
    Temab-A monotherapy demonstrated antitumor activity and a manageable safety profile in patients with advanced GEA. The findings support further clinical development of Temab-A, particularly in combination with other agents to improve outcomes for patients with 2L+ GEA.
    Clinical • P1 data • Journal • First-in-human
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET expression
    |
    telisotuzumab adizutecan (ABBV-400)
    14d
    A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2/3, N=900, Not yet recruiting, AbbVie
    New P2/3 trial
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • telisotuzumab adizutecan (ABBV-400)
    15d
    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=854, Recruiting, AbbVie | Trial completion date: Dec 2031 --> Nov 2036 | Trial primary completion date: Dec 2031 --> Nov 2036
    Trial completion date • Trial primary completion date • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • telisotuzumab adizutecan (ABBV-400)
    2ms
    M25-287: 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 (2024-518586-10-00)
    P2/3, N=44, Recruiting, AbbVie Deutschland GmbH & Co. KG
    New P2/3 trial • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    Tagrisso (osimertinib) • telisotuzumab adizutecan (ABBV-400)
    2ms
    M24-064: 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 Refractory Metastatic Colorectal Cancer expressing c-Met Protein Level Above Cutoff (2024-512804-20-00)
    P2/3, N=87, Not yet recruiting, AbbVie Deutschland GmbH & Co. KG
    New P2/3 trial • Adverse events
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • telisotuzumab adizutecan (ABBV-400)
    2ms
    M25-713: A Study to Assess Adverse Events, Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants with Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (2025-521124-29-00)
    P2/3, N=56, Recruiting, AbbVie Deutschland GmbH & Co. KG
    New P2/3 trial • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • Tagrisso (osimertinib) • carboplatin • pemetrexed • telisotuzumab adizutecan (ABBV-400)
    2ms
    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)
    3ms
    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
    3ms
    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)
    4ms
    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)