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    DRUG:

    taminadenant (NIR178)

    i
    Other names: PBF 509, NIR178, NIR 178, PBF-509, NIR-178, PBF509
    Associations

    News

    Trials
    Company:
    Novartis, Palobiofarma, Xoma
    Drug class:
    Adenosine A2A receptor antagonist
    Related drugs:
    Associations

    News

    Trials
    9ms
    DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2025 --> Feb 2025 | Trial primary completion date: Jul 2025 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases • Immuno-oncology
    |
    VHL (von Hippel-Lindau tumor suppressor) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • EPAS1 (Endothelial PAS domain protein 1) • SDHC (Succinate Dehydrogenase Complex Subunit C) • SDHD (Succinate Dehydrogenase Complex Subunit D) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2)
    |
    VHL mutation • SDHB mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    1year
    DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=180 --> 40
    Enrollment closed • Enrollment change • Combination therapy • IO biomarker • Metastases • Immuno-oncology
    |
    VHL (von Hippel-Lindau tumor suppressor) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • EPAS1 (Endothelial PAS domain protein 1) • SDHC (Succinate Dehydrogenase Complex Subunit C) • SDHD (Succinate Dehydrogenase Complex Subunit D) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2)
    |
    VHL mutation • SDHB mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    1year
    KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=77, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons
    Trial termination • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001) • KAZ954 • NZV930 • taminadenant (NIR178)
    over1year
    KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=77, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=145 --> 77
    Enrollment closed • Enrollment change • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001) • KAZ954 • NZV930 • taminadenant (NIR178)
    over1year
    KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=145, Recruiting, Novartis Pharmaceuticals | Trial completion date: Feb 2025 --> Sep 2023 | Trial primary completion date: Feb 2025 --> Sep 2023
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001) • KAZ954 • NZV930 • taminadenant (NIR178)
    over1year
    KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=145, Recruiting, Novartis Pharmaceuticals | Trial completion date: Aug 2024 --> Feb 2025 | Trial primary completion date: Aug 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    spartalizumab (PDR001) • KAZ954 • NZV930 • taminadenant (NIR178)
    over1year
    Early Adverse Event Derived Biomarkers in Predicting Clinical Outcomes in Patients with Advanced Non-Small Cell Lung Cancer Treated with Immunotherapy. (PubMed, Cancers (Basel))
    The study demonstrated the potential clinical utility of early AE-derived biomarkers in predicting positive and negative clinical outcomes. It could be TrAEs or combination of TrAEs and nonTrAEs from overall AEs, toxicity category AEs, to individual AEs with low-grade event leaning to encouraging effect and high-grade event to undesirable impact. Moreover, the methodology of the AE-derived biomarkers could change current AE analysis practice from a descriptive summary into modern informative statistics. It modernizes AE data analysis by helping clinicians discover novel AE biomarkers to predict clinical outcomes and facilitate the generation of vast clinically meaningful research hypotheses in a new AE content to fulfill the demands of precision medicine.
    Clinical data • Journal • Adverse events • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    Keytruda (pembrolizumab) • Zolinza (vorinostat) • taminadenant (NIR178)
    over1year
    A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2; Active, not recruiting --> Terminated; Sponsor decision
    Combination therapy • Trial termination • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8)
    |
    BRAF V600E • EGFR mutation • EGFR T790M • EGFR positive
    |
    VENTANA PD-L1 (SP142) Assay
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    almost2years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; This was a sponsor decision and was not a consequence of any safety concern
    Trial termination • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    2years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    over2years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2022 --> Oct 2022 | Trial primary completion date: Jun 2022 --> Oct 2022
    Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    over2years
    A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting
    Combination therapy • Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • EGFR mutation • EGFR T790M • EGFR positive
    |
    VENTANA PD-L1 (SP142) Assay
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    almost3years
    A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=376, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Mar 2022 --> Nov 2022
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • EGFR mutation • EGFR T790M • EGFR positive
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    almost3years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=64, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=220 --> 64 | Trial completion date: Jan 2022 --> Jun 2022 | Trial primary completion date: Jan 2022 --> Jun 2022
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)
    almost3years
    AdenONCO: Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1, N=92, Completed, Palobiofarma SL | Active, not recruiting --> Completed | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2020 --> Nov 2021 | Trial primary completion date: Oct 2020 --> Oct 2021
    Clinical • Trial completion • Phase classification • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK positive • ALK rearrangement
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    3years
    DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov)
    P1, N=180, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy • IO biomarker
    |
    VHL (von Hippel-Lindau tumor suppressor) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • EPAS1 (Endothelial PAS domain protein 1) • SDHC (Succinate Dehydrogenase Complex Subunit C) • SDHD (Succinate Dehydrogenase Complex Subunit D) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2)
    |
    VHL mutation • SDHB mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    3years
    A Phase I/Ib study of DFF332 as a single agent and in combination with Everolimus or Immuno-oncology therapies in patients with advanced/relapsed ccRCC and other malignancies with HIF2alpha stabilizing mutations. (clinicaltrialsregister.eu)
    P1, N=187, Ongoing, Novartis Pharma AG
    Clinical • New P1 trial • Combination therapy
    |
    VHL (von Hippel-Lindau tumor suppressor) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • EPAS1 (Endothelial PAS domain protein 1) • SDHC (Succinate Dehydrogenase Complex Subunit C) • SDHD (Succinate Dehydrogenase Complex Subunit D) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2)
    |
    VHL mutation • SDHB mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    over3years
    A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=376, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2023 --> Jun 2022 | Trial primary completion date: Jun 2023 --> Mar 2022
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • EGFR mutation • EGFR T790M
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    over3years
    DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov)
    P1, N=180, Not yet recruiting, Novartis Pharmaceuticals
    Clinical • New P1 trial • Combination therapy • IO biomarker
    |
    VHL (von Hippel-Lindau tumor suppressor) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • EPAS1 (Endothelial PAS domain protein 1) • SDHC (Succinate Dehydrogenase Complex Subunit C) • SDHD (Succinate Dehydrogenase Complex Subunit D) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2)
    |
    VHL mutation • SDHB mutation
    |
    everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
    almost4years
    A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=376, Recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2021 --> Jun 2023 | Trial primary completion date: Dec 2021 --> Jun 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • EGFR mutation • EGFR T790M
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    over4years
    AdenONCO: Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=92, Active, not recruiting, Palobiofarma SL | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK positive • ALK rearrangement
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    over4years
    A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=376, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: Jun 2021 --> Oct 2021
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • EGFR mutation • EGFR T790M
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    almost5years
    A Phase 2 Study of NIR178 in Combination With PDR001 in Patients With Solid Tumors and Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=310, Recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2020 --> Jun 2021 | Trial primary completion date: Nov 2020 --> Jun 2021
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • EGFR mutation • EGFR T790M
    |
    spartalizumab (PDR001) • taminadenant (NIR178)
    almost5years
    Study of Safety and Efficacy of Novel Immunotherapy Combinations in Patients With Triple Negative Breast Cancer (TNBC). (clinicaltrials.gov)
    P1, N=220, Recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2020 --> Jan 2022 | Trial primary completion date: Oct 2020 --> Jan 2022
    Clinical • Trial completion date • Trial primary completion date • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • LAG3 (Lymphocyte Activating 3)
    |
    HER-2 negative
    |
    Tabrecta (capmatinib) • spartalizumab (PDR001) • lacnotuzumab (MCS110) • Ilaris (canakinumab) • ieramilimab (LAG525) • taminadenant (NIR178)