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    DRUG:

    revdofilimab (ABBV-368)

    i
    Other names: ABBV-368, ABBV368, ABBV 368, PR1628103
    Associations

    News

    Trials
    Company:
    AbbVie
    Drug class:
    OX40 agonist
    Related drugs:
    Associations

    News

    Trials
    21h
    Phase 1b study of ABBV-368, tilsotolimod, budigalimab, and nab-paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma. (PubMed, J Immunother Cancer)
    The quadruple combination of ABBV-368, tilsotolimod, nab-paclitaxel, and budigalimab was well tolerated and demonstrated pharmacodynamic activity. Several patients had disease stabilization, but clinical responses were limited. Initial priming and T-cell immune activation were inadequate to overcome prior therapy resistance mechanisms including a hypothesized unfavorable tumor microenvironment. Future work investigating strategies to target this inhibitory tumor microenvironment with optimally scheduled immunotherapy combinations in selected patients and indications is urgently needed to improve patient outcomes.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma)
    |
    albumin-bound paclitaxel • budigalimab (ABBV-181) • revdofilimab (ABBV-368) • tilsotolimod (IMO-2125)
    8ms
    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)
    over1year
    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: Sep 2024 --> Mar 2025 | Trial primary completion date: Sep 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    carboplatin • albumin-bound paclitaxel • budigalimab (ABBV-181) • giloralimab (ABBV-927) • revdofilimab (ABBV-368)
    almost2years
    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: Nov 2023 --> Sep 2024 | Trial primary completion date: Nov 2023 --> Sep 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    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)
    3years
    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 | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    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)
    over3years
    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, Recruiting, AbbVie | Trial completion date: Jul 2024 --> Nov 2023
    Trial completion date • Metastases
    |
    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)
    over3years
    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, Recruiting, AbbVie | Trial completion date: Dec 2023 --> Jul 2024
    Trial 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)
    almost4years
    A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=139, Completed, AbbVie | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    budigalimab (ABBV-181) • revdofilimab (ABBV-368)
    4years
    A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=170, Active, not recruiting, AbbVie | Trial completion date: Sep 2021 --> Feb 2022 | Trial primary completion date: Sep 2021 --> Feb 2022
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    budigalimab (ABBV-181) • revdofilimab (ABBV-368)
    over5years
    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, Recruiting, AbbVie | Trial primary completion date: May 2023 --> Nov 2023
    Clinical • 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)
    over5years
    A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=140, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | Trial completion date: Jan 2021 --> Sep 2021 | Trial primary completion date: Jan 2021 --> Sep 2021
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    budigalimab (ABBV-181) • revdofilimab (ABBV-368)
    almost6years
    [VIRTUAL] A phase I study of CD40 agonist ABBV-927 plus OX40 agonist ABBV-368 with or without the PD-1 inhibitor budigalimab in patients with advanced solid tumors. (ASCO 2020)
    Screening began on 21 May 2019, and enrollment is ongoing. Research Funding: Abbvie, Inc
    Clinical • P1 data
    |
    TNFRSF4 (TNF Receptor Superfamily Member 4) • CD40 (CD40 Molecule)
    |
    budigalimab (ABBV-181) • giloralimab (ABBV-927) • revdofilimab (ABBV-368)