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Therapy Name	SAR405838
Synonyms
Therapy Description	SAR405838 (MI-77301) binds to MDM2 and inhibits MDM2-p53 interaction, resulting in activation of wild-type p53 signaling and decreased tumor growth (PMID: 25145672, PMID: 30585255, PMID: 31619389).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
SAR405838		MI-77301\|MI-773\|MI773\|SAR-405838	MDM2 Inhibitor 23	SAR405838 (MI-77301) binds to MDM2 and inhibits MDM2-p53 interaction, resulting in activation of wild-type p53 signaling and decreased tumor growth (PMID: 25145672, PMID: 30585255, PMID: 31619389).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
TP53 wild-type	salivary gland adenoid cystic carcinoma	predicted - sensitive	SAR405838	Preclinical - Pdx	Actionable	In a preclinical study, treatment with SAR405838 (MI-773) resulted in activation of Mdm2 and Tp53 in patient-derived salivary gland adenoid cystic carcinoma (ACC) cells in culture, and led to induction of apoptosis and tumor regression in ACC patient-derived xenograft (PDX) models with wild-type TP53 (PMID: 26936915).	26936915
TP53 wild-type	breast cancer	predicted - sensitive	SAR405838	Preclinical - Pdx	Actionable	In a preclinical study, SAR405838 (MI-77301) induced p53 signaling and inhibited tumor growth in patient-derived xenograft models of endocrine therapy-resistant breast cancer with wild-type TP53, and induced cell-cycle arrest and inhibited growth of patient-derived endocrine therapy-resistant breast cancer cells in culture (PMID: 27765850).	27765850
TP53 wild-type	acute leukemia	sensitive	SAR405838	Preclinical - Cell line xenograft	Actionable	In a preclinical study, SAR405838 inhibited growth of TP53 wild-type acute leukemia cells in culture and resulted in tumor regression in cell line xenograft models (PMID: 25145672).	25145672
TP53 wild-type	prostate cancer	sensitive	SAR405838	Preclinical - Cell line xenograft	Actionable	In a preclinical study, SAR405838 inhibited growth of TP53 wild-type prostate cancer cells in culture and resulted in tumor regression in cell line xenograft models (PMID: 25145672).	25145672
TP53 wild-type	colon cancer	sensitive	SAR405838	Preclinical - Cell line xenograft	Actionable	In a preclinical study, SAR405838 inhibited growth of TP53 wild-type colon cancer cells in culture and resulted in tumor regression in cell line xenograft models (PMID: 25145672).	25145672

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT01636479	Phase I	SAR405838	Phase 1 Safety Testing of SAR405838	Completed	USA \| NLD \| FRA	0

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