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    DRUG:

    AAA603

    i
    Other names: AAA603, lutetium-177 NeoBOMB1, 177Lu-NeoBOMB1, [177Lu]-NeoB, 177Lu-NeoB, 177LuNeoBOMB1, [177Lu]Lu-NeoB, AAA 603, AAA-603
    Associations

    News

    Trials
    Company:
    Novartis
    Drug class:
    Beta radiation emitter, GRPR antagonist
    Related drugs:
    Associations

    News

    Trials
    2ms
    Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=48, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jun 2026 --> Aug 2031
    Trial completion date • Combination therapy
    |
    temozolomide • AAA603
    4ms
    NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (clinicaltrials.gov)
    P1, N=36, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
    5ms
    [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Dec 2031 --> Dec 2026
    Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    6ms
    A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. (clinicaltrials.gov)
    P1/2, N=58, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    capecitabine • AAA603
    6ms
    [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer (clinicaltrials.gov)
    P1, N=48, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2030 --> Dec 2031 | Trial primary completion date: Jan 2030 --> Dec 2031
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    8ms
    Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=48, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: Nov 2025 --> Jun 2026 | Trial primary completion date: Oct 2025 --> May 2026
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
    |
    temozolomide • AAA603
    8ms
    NeoRay: [177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-NeoB Lesion Uptake (clinicaltrials.gov)
    P1/2, N=51, Recruiting, Advanced Accelerator Applications | N=86 --> 51 | Trial completion date: Oct 2025 --> Dec 2026
    Enrollment change • Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • CDK4 (Cyclin-dependent kinase 4)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative
    |
    AAA603
    8ms
    NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Novartis Pharmaceuticals
    New P1 trial • Metastases
    |
    Pluvicto (lutetium Lu 177 vipivotide tetraxetan) • Lutathera (lutetium Lu 177 dotatate) • AAA603
    10ms
    A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. (clinicaltrials.gov)
    P1/2, N=58, Not yet recruiting, Novartis Pharmaceuticals
    New P1/2 trial
    |
    capecitabine • AAA603
    1year
    [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2-, GRPR+ Breast Cancer (clinicaltrials.gov)
    P1, N=45, Recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2030 --> Oct 2029 | Trial primary completion date: Jun 2027 --> Oct 2029
    Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • PGR expression
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    1year
    Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2025 --> Sep 2025
    Trial completion date • Combination therapy
    |
    temozolomide • AAA603
    1year
    [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2-, GRPR+ Breast Cancer (clinicaltrials.gov)
    P1, N=45, Recruiting, Novartis Pharmaceuticals | Trial primary completion date: Nov 2024 --> Jun 2027
    Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • PGR expression
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    1year
    [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2-, GRPR+ Breast Cancer (clinicaltrials.gov)
    P1, N=45, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • PGR expression
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    over1year
    The Balance Between the Therapeutic Efficacy and Safety of [Lu]Lu-NeoB in a Preclinical Prostate Cancer Model. (PubMed, Mol Imaging Biol)
    Treatment with [Lu]Lu-NeoB is effective in a preclinical PCa model. Adjusting the administered dose could positively impact the risk-benefit balance as a higher dose might not lead to an increased therapeutic effect, but it may lead to an increase in toxicological effects in healthy organs such as the kidneys.
    Preclinical • Journal
    |
    AAA603
    over1year
    Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=48, Not yet recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2025 --> Dec 2025 | Initiation date: Aug 2023 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Oct 2025
    Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
    |
    temozolomide • AAA603
    over1year
    [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2-, GRPR+ Breast Cancer (clinicaltrials.gov)
    P1, N=45, Not yet recruiting, Novartis Pharmaceuticals
    New P1 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • PGR expression
    |
    Kisqali (ribociclib) • fulvestrant • goserelin acetate • AAA603
    over1year
    NeoRay: [177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-NeoB Lesion Uptake (clinicaltrials.gov)
    P1/2, N=86, Recruiting, Advanced Accelerator Applications | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Aug 2023 --> Sep 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • CDK4 (Cyclin-dependent kinase 4)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative
    |
    AAA603