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    DRUG:

    budigalimab (ABBV-181)

    i
    Other names: ABBV-181, ABBV 181, ABBV181
    Company:
    AbbVie
    Drug class:
    PD1 inhibitor
    Related drugs:
    4d
    A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors (clinicaltrials.gov)
    P1, N=220, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open • Adverse events • First-in-human
    |
    budigalimab (ABBV-181)
    8d
    Therapeutic Applications and Target Strategies of Antibody-Drug Conjugates in Ovarian Cancer. (PubMed, Iran J Pharm Res)
    This review summarizes a range of ADCs targeting tumor-associated antigens in ovarian cancer, including mirvetuximab soravtansine (MIRV), trastuzumab deruxtecan (T-DXd), datopotamab deruxtecan (Dato-DXd), sacituzumab tirumotecan (SKB-264), PF-06664178, anetumab ravtansine (BAY 94-9343), BMS-986148, DMOT4039A, RC88, lifastuzumab vedotin (DNIB0600A), upifitamab rilsodotin (ABBV-181), ZW220, DMUC4064A, and sofituzumab vedotin (DMUC5754A). The ADCs hold significant potential to reshape the treatment landscape for ovarian cancer by providing targeted therapeutic options. Further research is required to optimize patient selection, address resistance mechanisms, and improve safety profiles.
    Review • Journal
    |
    MUC4 (Mucin 4, Cell Surface Associated)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Elahere (mirvetuximab soravtansine-gynx) • budigalimab (ABBV-181) • Datroway (datopotamab deruxtecan-dlnk) • Jiataile (sacituzumab tirumotecan) • anetumab ravtansine (BAY 94-9343) • upifitamab rilsodotin (XMT-1536) • RG7600 • lifastuzumab vedotin (DNIB0600A) • RG7882 • ZW220 • BMS-986148
    21d
    A Study to Assess the Adverse Events, Change in Disease Activity, and How Oral ABBV-711 Tablets Move Through the Body as a Monotherapy and in Combination With Intravenously Infused Budigalimab (ABBV-181), in Adults With Advanced Squamous Tumors (clinicaltrials.gov)
    P1, N=220, Not yet recruiting, AbbVie
    New P1 trial • Adverse events • First-in-human
    |
    budigalimab (ABBV-181)
    1m
    A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382 (clinicaltrials.gov)
    P2, N=163, Terminated, AbbVie | Completed --> Terminated; Company Decision
    Trial termination • Adverse events
    |
    CD4 (CD4 Molecule)
    |
    budigalimab (ABBV-181)
    2ms
    A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=27, Terminated, AbbVie | N=192 --> 27 | Trial completion date: Jan 2028 --> Oct 2025 | Recruiting --> Terminated | Trial primary completion date: Jan 2028 --> Oct 2025; Strategic considerations
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • First-in-human
    |
    budigalimab (ABBV-181)
    2ms
    M23-385: Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=288, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting
    Enrollment closed • Adverse events • First-in-human
    |
    EGFR (Epidermal growth factor receptor) • SEZ6 (Seizure Related 6 Homolog)
    |
    EGFR mutation • IDH wild-type
    |
    cisplatin • carboplatin • budigalimab (ABBV-181) • ABBV-706
    2ms
    A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382 (clinicaltrials.gov)
    P2, N=163, Completed, AbbVie | Active, not recruiting --> Completed | Trial completion date: Mar 2027 --> Sep 2025 | Trial primary completion date: Mar 2027 --> Sep 2025
    Trial completion • Trial completion date • Trial primary completion date • Adverse events
    |
    CD4 (CD4 Molecule)
    |
    budigalimab (ABBV-181)
    4ms
    M23-385: Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=350, Recruiting, AbbVie | Trial completion date: Nov 2027 --> Jun 2026 | Trial primary completion date: Nov 2027 --> Jun 2026
    Trial completion date • Trial primary completion date • Adverse events
    |
    EGFR (Epidermal growth factor receptor) • SEZ6 (Seizure Related 6 Homolog)
    |
    EGFR mutation • IDH wild-type
    |
    cisplatin • carboplatin • budigalimab (ABBV-181) • ABBV-706
    4ms
    A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=150, Active, not recruiting, AbbVie | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative • PD-L1 negative
    |
    carboplatin • albumin-bound paclitaxel • budigalimab (ABBV-181) • giloralimab (ABBV-927) • revdofilimab (ABBV-368)
    4ms
    A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=163, Active, not recruiting, AbbVie | Trial completion date: Sep 2025 --> Mar 2026 | Trial primary completion date: Sep 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    budigalimab (ABBV-181) • giloralimab (ABBV-927)
    4ms
    LIVIGNO-2: A Study to Assess the Dose, Adverse Events, and Change in Disease Activity of Livmoniplimab as an Intravenous (IV) Solution in Combination With Budigalimab as an IV Solution in Adult Participants With Hepatocellular Carcinoma (HCC) (clinicaltrials.gov)
    P2/3, N=660, Recruiting, AbbVie | Active, not recruiting --> Recruiting
    Enrollment open
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)
    4ms
    LIVIGNO-3: Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously (IV) Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma (UC) (clinicaltrials.gov)
    P2, N=150, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    gemcitabine • paclitaxel • docetaxel • budigalimab (ABBV-181) • livmoniplimab (ABBV-151)