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    DRUG:

    telisotuzumab adizutecan (ABBV-400)

    i
    Other names: ABBV-400
    Company:
    AbbVie
    Drug class:
    Topoisomerase I inhibitor, c-MET-targeted antibody-drug conjugate
    Related drugs:
    1d
    Genomic alterations in circulating tumor DNA (ctDNA) and response to ABBV-400 treatment in patients with advanced solid tumors (AIOM 2024)
    The ADC ABBV-400 comprises the c-Met–targeting antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload. ABBV-400 showed promising preliminary efficacy, with molecular and radiographic responses in pts with advanced solid tumors with heterogeneous genomic profiles, including pts with high TMB and KRAS mutations.
    Clinical • Tumor mutational burden • Circulating tumor DNA • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • LRP1B (LDL Receptor Related Protein 1B) • PTPRT (Protein tyrosine phosphatase receptor type T)
    |
    KRAS mutation • TMB-H • MET overexpression • PTPRT mutation
    |
    GuardantINFINITY™
    |
    telisotuzumab adizutecan (ABBV-400) • telisotuzumab (h224G11)
    21d
    Study to Assess Adverse Events and How Intravenously (IV) Infused ABBV-400 Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=27, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events • Metastases
    |
    telisotuzumab adizutecan (ABBV-400)
    2ms
    AndroMETa-GEA: A Study to Evaluate the Adverse Events, Efficacy, and Optimal Dose of Intravenous (IV) ABBV-400 in Combination With IV Fluorouracil, Leucovorin, and Budigalimab in Adult Participants With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=180, Not yet recruiting, AbbVie
    New P2 trial
    |
    5-fluorouracil • oxaliplatin • budigalimab (ABBV-181) • leucovorin calcium • telisotuzumab adizutecan (ABBV-400)
    2ms
    AndroMETa-CRC-: A Study to Assess Adverse Events and How Intravenously (IV) Infused ABBV-400 Moves Through the Body as a Monotherapy Compared to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=460, Not yet recruiting, AbbVie
    New P3 trial • Adverse events • Metastases
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • telisotuzumab adizutecan (ABBV-400)
    5ms
    Study to Assess Adverse Events and How Intravenously (IV) Infused ABBV-400 Moves Through the Body of Adult Participants With Unresectable Locally Advanced/Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=27, Not yet recruiting, AbbVie
    New P1/2 trial • Adverse events • Metastases
    |
    telisotuzumab adizutecan (ABBV-400)
    1year
    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=206, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • telisotuzumab adizutecan (ABBV-400)
    1year
    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=220, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    telisotuzumab adizutecan (ABBV-400)
    1year
    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=206, Not yet recruiting, AbbVie
    New P2 trial • Adverse events • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • telisotuzumab adizutecan (ABBV-400)
    1year
    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=220, Not yet recruiting, AbbVie
    New P1 trial • Adverse events • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    telisotuzumab adizutecan (ABBV-400)
    over1year
    Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 (clinicaltrials.gov)
    P1, N=460, Recruiting, AbbVie | N=300 --> 460
    Enrollment change • Adverse events • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • EGFR wild-type
    |
    telisotuzumab adizutecan (ABBV-400)
    over1year
    Efficacy of ABBV-400 monotherapy in patients with MET gene amplified advanced solid tumors (ESMO 2023)
    Background Anti–c-Met (MET protein) antibody-drug conjugate ABBV-400 comprises monoclonal antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor via a stable, cleavable linker. Conclusions ABBV-400 monotherapy showed promising tolerability and efficacy in pts with various MET amp advanced solid tumors. Based on these results, MET amp cohort will be expanded to 60 more pts.
    Clinical • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET overexpression
    |
    telisotuzumab adizutecan (ABBV-400) • telisotuzumab (h224G11)
    over1year
    Genomic alterations in circulating tumor DNA (ctDNA) and response to ABBV-400 treatment in patients with advanced solid tumors (ESMO 2023)
    The antibody-drug conjugate ABBV-400 comprises the c-Met–targeting antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload. A molecular response was observed in 48% (14/29) of all evaluated pts and 47% (8/17) of pts with CRC; median change from baseline tumor size was -22.5% and -20.3%, respectively. Table: 163P Pts with molecular response and correlation between baseline biomarker status and radiographic response Conclusions ABBV-400 showed promising preliminary efficacy, with molecular and radiographic responses in pts with advanced solid tumors with heterogeneous genomic profiles, including in pts with high TMB and KRAS mutations.
    Clinical • Tumor mutational burden • Circulating tumor DNA • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • MSI (Microsatellite instability) • LRP1B (LDL Receptor Related Protein 1B) • PTPRT (Protein tyrosine phosphatase receptor type T)
    |
    KRAS mutation • TMB-H • MET overexpression • PTPRT mutation
    |
    GuardantINFINITY™
    |
    telisotuzumab adizutecan (ABBV-400) • telisotuzumab (h224G11)
    over1year
    Dose escalation results from a first-in-human study of ABBV-400, a novel c-Met–targeting antibody-drug conjugate, in advanced solid tumors. (ASCO 2023)
    The antibody-drug conjugate (ADC) ABBV-400 consists of the c-Met–targeting antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor (Top1i) payload. On the basis of DLTs, a maximum tolerated dose of ABBV-400 was identified. At this dose, safety results appear comparable with other Top1i ADCs. Promising antitumor activity was seen with ABBV-400 across tumor types, justifying further evaluation in the ongoing dose expansion in NSCLC, GEA, and CRC.
    P1 data • Metastases
    |
    EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR wild-type • MET overexpression • MET expression
    |
    telisotuzumab adizutecan (ABBV-400) • telisotuzumab (h224G11)
    over1year
    Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 (clinicaltrials.gov)
    P1, N=300, Recruiting, AbbVie | N=220 --> 300 | Trial completion date: Jun 2025 --> Nov 2025 | Trial primary completion date: Jun 2025 --> Nov 2025
    Enrollment change • Trial completion date • Trial primary completion date • Adverse events • Metastases
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR wild-type • MET overexpression
    |
    telisotuzumab adizutecan (ABBV-400)
    almost3years
    Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 (clinicaltrials.gov)
    P1, N=190, Recruiting, AbbVie | N=100 --> 190
    Enrollment change • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR wild-type • MET overexpression
    |
    telisotuzumab adizutecan (ABBV-400)
    3years
    Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Non-Small Cell Lung Receiving Intravenous (IV) ABBV-400 (clinicaltrials.gov)
    P1, N=100, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR wild-type • MET positive
    |
    telisotuzumab adizutecan (ABBV-400)
    3years
    Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer Receiving Intravenous (IV) ABBV-400 (clinicaltrials.gov)
    P1, N=100, Not yet recruiting, AbbVie
    Clinical • New P1 trial • Adverse events
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET positive
    |
    telisotuzumab adizutecan (ABBV-400)