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Therapy Name Siremadlin
Synonyms
Therapy Description

Siremadlin (HDM201) binds to MDM2 and inhibits its interaction with p53, which prevents p53 degradation and potentially leads to restoration of p53 signaling and increased tumor cell death (PMID: 30899200, PMID: 27542305).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Siremadlin HDM201|HDM-201|NVP-HDM201 MDM2 Inhibitor 23 Siremadlin (HDM201) binds to MDM2 and inhibits its interaction with p53, which prevents p53 degradation and potentially leads to restoration of p53 signaling and increased tumor cell death (PMID: 30899200, PMID: 27542305).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TP53 wild-type Advanced Solid Tumor predicted - sensitive Siremadlin Preclinical - Cell line xenograft Actionable In a preclinical study, HDM201 treatment resulted in tumor regression in various cell line xenograft models of Tp53 wild-type tumors (Cancer Res 2016;76(14 Suppl):Abstract nr 4855). detail...
TP53 wild-type Advanced Solid Tumor predicted - sensitive Siremadlin Phase I Actionable In a Phase I trial, Siremadlin (HDM201) treatment demonstrated safety and resulted in an overall response rate (ORR) of 3.5% (4/115; all partial responses) and disease control rate (DCR) of 36.5% in patients with TP53 wild-type advanced solid tumors, and at the recommended dose for expansion (120 mg), resulted in an ORR of 10.5% (3/29) and DCR of 44.8% in all patients, and a DCR of 83.3% (10/12) in patients with liposarcoma (PMID: 34862243; NCT02143635). 34862243
TP53 wild-type acute myeloid leukemia predicted - sensitive Siremadlin Phase I Actionable In a Phase I trial, Siremadlin (HDM201) treatment demonstrated safety and resulted in overall response rates of 4.2% (1/24), 20% (3/15), and 22.2% (6/27) for the recommended expansion doses of 120 mg, 250 mg, and 45 mg, respectively, in patients with TP53 wild-type acute myeloid leukemia (PMID: 34862243; NCT02143635). 34862243

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  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02143635 Phase I Siremadlin Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt Completed USA | NLD | FRA | ESP | DEU 3
NCT05447663 Phase Ib/II Siremadlin A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant Terminated ITA | ESP | DEU 0
NCT02780128 Phase I Siremadlin Ceritinib + Ribociclib Trametinib Next Generation Personalized Neuroblastoma Therapy Terminated USA 0


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