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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:
    1d
    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, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open
    |
    5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • telisotuzumab adizutecan (ABBV-400)
    13d
    AndroMETa-CRC-064: A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=74, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | N=460 --> 74 | Trial completion date: Oct 2028 --> Aug 2027 | Trial primary completion date: Oct 2028 --> Aug 2027
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Adverse events
    |
    telisotuzumab adizutecan (ABBV-400)
    1m
    Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Adizutecan (ABBV-400) Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | Trial completion date: Sep 2028 --> Dec 2027 | Trial primary completion date: Sep 2028 --> Dec 2027
    Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET expression
    |
    telisotuzumab adizutecan (ABBV-400)
    1m
    Phase I Study of Telisotuzumab Adizutecan (Temab-A, ABBV-400), a Novel c-Met Antibody-Drug Conjugate, in Patients With Late-Line Colorectal Cancer and Advanced Solid Tumors. (PubMed, J Clin Oncol)
    Temab-A at 2.4 mg/kg once every 3 weeks has a tolerable and manageable safety profile, with promising antitumor activity.
    P1 data • Journal • First-in-human
    |
    BRAF (B-raf proto-oncogene) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    BRAF wild-type
    |
    telisotuzumab adizutecan (ABBV-400) • telisotuzumab (h224G11)
    2ms
    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 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
    A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=700, Not yet recruiting, AbbVie
    New P3 trial
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • telisotuzumab adizutecan (ABBV-400)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    4ms
    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)