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|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Siremadlin||HDM201|HDM-201|NVP-HDM201||MDM2 Inhibitor 20||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).|
|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|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT02780128||Phase I||Siremadlin Ceritinib + Ribociclib Trametinib||Next Generation Personalized Neuroblastoma Therapy||Recruiting||USA||0|
|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 | FRA | ESP | DEU||4|