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    DRUG:

    visugromab (CTL-002)

    i
    Other names: CTL-002
    Company:
    CatalYm
    Drug class:
    GDF15 inhibitor
    Related drugs:
    10d
    GDFATHERHCC01: Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI) Compared to Double Placebo and a TKI in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure (clinicaltrials.gov)
    P2, N=104, Recruiting, CatalYm GmbH | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • visugromab (CTL-002)
    1m
    CTL-002-004: A phase 2 placebo-controlled trial to investigate visugromab and nivolumab with or without docetaxel in second-line treatment of participants with metastatic non-squamous non-small cell lung cancer (NSCLC) (2024-516794-70-00)
    P1/2, N=103, Recruiting, CatalYm GmbH
    New P1/2 trial
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation
    |
    Opdivo (nivolumab) • docetaxel • visugromab (CTL-002)
    1m
    CTL-002-006: Visugromab in Cachexia International Trial (2025-523533-25-00)
    P2/3, N=354, Not yet recruiting, CatalYm GmbH
    New P2/3 trial
    |
    visugromab (CTL-002)
    1m
    CTL-002-004: A phase 2 placebo-controlled trial to investigate visugromab and nivolumab with or without docetaxel in second-line treatment of participants with metastatic non-squamous non-small cell lung cancer (NSCLC) (2024-516794-70-00)
    P1/2, N=89, Recruiting, CatalYm GmbH
    New P1/2 trial
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation
    |
    Opdivo (nivolumab) • docetaxel • visugromab (CTL-002)
    1m
    CTL-002-005: Visugromab, nivolumab and lenvatinib compared to double placebo and lenvatinib in unresectable or metastatic hepatocellular carcinoma post anti-PD-(L)1 failure (2025-520675-86-00)
    P1/2, N=59, Not yet recruiting, CatalYm GmbH
    New P1/2 trial
    |
    Opdivo (nivolumab) • Lenvima (lenvatinib) • visugromab (CTL-002)
    1m
    CTL-002-006: Visugromab in Cachexia International Trial (2025-523533-25-00)
    P2/3, N=154, Not yet recruiting, CatalYm GmbH
    New P2/3 trial
    |
    visugromab (CTL-002)
    2ms
    GDFATHER-01: First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER) (clinicaltrials.gov)
    P1/2, N=263, Active, not recruiting, CatalYm GmbH | Trial completion date: Oct 2027 --> Apr 2030 | Trial primary completion date: Oct 2025 --> Apr 2028
    Trial completion date • Trial primary completion date • Checkpoint inhibition • First-in-human
    |
    visugromab (CTL-002)
    3ms
    VINCIT: Visugromab in Cachexia International Trial (clinicaltrials.gov)
    P2/3, N=518, Recruiting, CatalYm GmbH | Not yet recruiting --> Recruiting
    Enrollment open
    |
    visugromab (CTL-002)
    4ms
    Decoding GDF15: Impact on prostate cancer metabolism, chemoresistance, and clinical applications. (PubMed, Chin Med J (Engl))
    Clinically, GDF15 has shown potential as a biomarker, offering diagnostic precision and prognostic value, particularly when combined with established markers such as prostate-specific antigen. The review concludes with a discussion on several monoclonal antibodies targeting GDF15 in clinical trials, such as AV-380, NGM120, Visugromab, and AZD8853, highlighting promising strategies for novel therapies and precision medicine.
    Journal
    |
    GDF15 (Growth differentiation factor 15)
    |
    visugromab (CTL-002) • AZD8853 • NGM120
    4ms
    Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (clinicaltrials.gov)
    P2, N=131, Recruiting, CatalYm GmbH
    New P2 trial
    |
    Opdivo (nivolumab) • docetaxel • visugromab (CTL-002)
    5ms
    GDFATHERHCC01: Visugromab, Nivolumab and a Tyrosine Kinase Inhibitor (TKI) Compared to Double Placebo and a TKI in Unresectable or Metastatic Hepatocellular Carcinoma Post Anti-PD-(L)1 Failure (clinicaltrials.gov)
    P2, N=104, Not yet recruiting, CatalYm GmbH
    New P2 trial
    |
    Opdivo (nivolumab) • visugromab (CTL-002)
    7ms
    GDFATHER-NSCLC-01: Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC (clinicaltrials.gov)
    P2, N=107, Recruiting, CatalYm GmbH | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • visugromab (CTL-002)