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    8ms
    Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma (clinicaltrials.gov)
    P1, N=12, Suspended, Fox Chase Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Recruiting --> Suspended | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial suspension • Trial primary completion date • Combination therapy • Metastases
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • CBL137 IV
    over1year
    CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma (clinicaltrials.gov)
    P1/2, N=95, Recruiting, Children's Oncology Group | Active, not recruiting --> Recruiting | N=38 --> 95
    Enrollment open • Enrollment change
    |
    AFP (Alpha-fetoprotein)
    |
    CBL137 IV
    over1year
    Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma (clinicaltrials.gov)
    P1, N=12, Recruiting, Fox Chase Cancer Center | Trial primary completion date: Nov 2024 --> Mar 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • CBL137 IV
    over2years
    CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma (clinicaltrials.gov)
    P1/2, N=38, Active, not recruiting, Children's Oncology Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    AFP (Alpha-fetoprotein)
    |
    CBL137 IV
    almost3years
    CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma (clinicaltrials.gov)
    P1/2, N=38, Recruiting, Children's Oncology Group | Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2026 --> Dec 2026
    Enrollment open • Trial primary completion date
    |
    AFP (Alpha-fetoprotein)
    |
    CBL137 IV
    almost3years
    CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma (clinicaltrials.gov)
    P1/2, N=38, Not yet recruiting, Children's Oncology Group | Trial primary completion date: Dec 2026 --> Feb 2026
    Trial primary completion date
    |
    AFP (Alpha-fetoprotein)
    |
    CBL137 IV
    3years
    CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma (clinicaltrials.gov)
    P1/2, N=38, Not yet recruiting, Children's Oncology Group | Initiation date: Sep 2021 --> Dec 2021
    Clinical • Trial initiation date
    |
    AFP (Alpha-fetoprotein)
    |
    CBL137 IV
    over3years
    CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma (clinicaltrials.gov)
    P1/2, N=4, Not yet recruiting, Children's Oncology Group
    Clinical • New P1/2 trial
    |
    AFP (Alpha-fetoprotein)
    |
    CBL137 IV
    almost4years
    CBL0137 increases the targeting efficacy of Rovalpituzumab tesirine against tumour-initiating cells in small cell lung cancer. (PubMed, Br J Cancer)
    Therefore, we investigated the potential effect of combining Rova-T and CBL in SCLC to eradicate TICs more effectively. Our preclinical studies report a novel and highly translatable therapeutic strategy of dual targeting TICs using Rova-T in combination with CBL to potentially increase survival of SCLC patients.
    Clinical • Journal
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    DLL3 (Delta Like Canonical Notch Ligand 3) • CBL (Cbl proto-oncogene)
    |
    Rova-T (rovalpituzumab tesirine) • CBL137 IV
    4years
    CBL0137 administration suppresses human hepatocellular carcinoma cells proliferation and induces apoptosis associated with multiple cell death related proteins. (PubMed, Neoplasma)
    Moreover, HE staining and IHC staining for Ki-67 indicated that CBL0137 treatment could obviously induce cell apoptosis and suppress cell proliferation. CBL0137 treatment could effectively inhibit HCC cell proliferation and induce cell apoptosis associated with multiple factors expression.
    Journal • PARP Biomarker
    |
    TP53 (Tumor protein P53) • CBL (Cbl proto-oncogene) • NFKB1 (Nuclear factor of kappa light polypeptide gene enhancer in B-cells 1) • CASP3 (Caspase 3) • CASP8 (Caspase 8) • CASP9 (Caspase 9) • CASP7 (Caspase 7)
    |
    TP53 expression • BAX expression
    |
    CBL137 IV
    over4years
    [VIRTUAL] Results of a completed first-in-human phase Ib dose-escalation study of oral CBL0137 in patients with advanced solid tumors. (ASCO 2020)
    The Phase 2 RDR for oral CBL0137 was established as 180 mg QD x 14 days in 28-day cycles based on bone marrow and gastrointestinal DLTs at 200 mg QD. CBL0137 showed a manageable safety profile with efficacy signals. Further study as a component of combinations is planned.
    Clinical • P1 data
    |
    HIF1A (Hypoxia inducible factor 1, alpha subunit)
    |
    CBL137 IV
    over4years
    ACTL6A interacts with p53 in acute promyelocytic leukemia cell lines to affect differentiation via the Sox2/Notch1 signaling pathway. (PubMed, Cell Signal)
    Meanwhile, CBL0137, an activator of p53, decreased the expression of ACTL6A and promoted differentiation in NB4 and HL-60 cells. These findings suggest that the inhibition of ACTL6A promotes differentiation via the Sox2 and Notch1 signaling pathways. Furthermore, the differentiation promoted by inhibiting ACTL6A could be regulated by p53 via its physical interaction with ACTL6A.
    Preclinical • Journal
    |
    NOTCH1 (Notch 1) • SOX2
    |
    CBL137 IV
    over4years
    Potent anti-leukemic activity of curaxin CBL0137 against MLL-rearranged leukemia. (PubMed, Int J Cancer)
    CBL0137 exerted its anti-cancer effect by trapping Facilitator of Chromatin Transcription (FACT) into chromatin, simultaneously activating the p53 pathway and inducing an Interferon response. Our findings support further preclinical evaluation of CBL0137 as a new approach for the treatment of MLL-r leukemia.
    Journal
    |
    CBL137 IV