Therapy Detail

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Therapy Name	BAY1125976
Synonyms
Therapy Description	BAY1125976 inhibits the activity of AKT1/2, which may result in reduced tumor cell proliferation and decreased growth of tumors with activated PI3K/AKT/mTOR signaling (PMID: 27699769, PMID: 31835495).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
BAY1125976		BAY 1125976\|BAY-1125976	Akt1 Inhibitor 7 Akt2 Inhibitor 2	BAY1125976 inhibits the activity of AKT1/2, which may result in reduced tumor cell proliferation and decreased growth of tumors with activated PI3K/AKT/mTOR signaling (PMID: 27699769, PMID: 31835495).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
PIK3CA E545K	breast cancer	sensitive	BAY1125976	Preclinical - Cell line xenograft	Actionable	In a preclinical study, BAY1125976 inhibited proliferation of a breast cancer cell line harboring PIK3CA E545K in culture, and inhibited AKT signaling and tumor growth in xenograft models (PMID: 27699769).	27699769
PIK3CA H1047R	breast cancer	sensitive	BAY1125976	Preclinical - Cell line xenograft	Actionable	In a preclinical study, BAY1125976 inhibited proliferation of breast cancer cell lines harboring PIK3CA H1047R in culture, and inhibited AKT signaling and tumor growth in a PIK3CA H1047R-mutant cell line xenograft model (PMID: 27699769).	27699769
PIK3CA H1047R PTEN E307K	breast cancer	sensitive	BAY1125976	Preclinical - Cell culture	Actionable	In a preclinical study, BAY1125976 inhibited proliferation of a breast cancer cell line harboring PIK3CA H1047R and PTEN E307K in culture (PMID: 27699769).	27699769
PIK3CA K111N	breast cancer	sensitive	BAY1125976	Preclinical - Cell culture	Actionable	In a preclinical study, BAY1125976 inhibited proliferation of a breast cancer cell line harboring PIK3CA K111N in culture (PMID: 27699769).	27699769
PIK3CA P539R	breast cancer	sensitive	BAY1125976	Preclinical - Cell culture	Actionable	In a preclinical study, BAY1125976 inhibited proliferation of a breast cancer cell line harboring PIK3CA P539R in culture (PMID: 27699769).	27699769
PTEN L108R	breast cancer	sensitive	BAY1125976	Preclinical - Cell culture	Actionable	In a preclinical study, BAY1125976 inhibited proliferation of a breast cancer cell line harboring PTEN L108R in culture (PMID: 27699769).	27699769
PTEN T319fs	breast cancer	sensitive	BAY1125976	Preclinical - Cell culture	Actionable	In a preclinical study, BAY1125976 inhibited proliferation of a breast cancer cell line harboring PTEN T319fs*1 in culture (PMID: 27699769).	27699769
PIK3CA act mut	Advanced Solid Tumor	sensitive	BAY1125976	Preclinical	Actionable	In a preclinical study, BAY1125976 demonstrated anti-tumor efficacy in multiple xenograft tumor models of different cancers with PIK3CA mutations or PTEN deletions and displayed synergy with other anti-cancer therapies (Cancer Res 2013;73(8 Suppl):Abstract nr 2050).	detail...
PTEN loss	Advanced Solid Tumor	sensitive	BAY1125976	Preclinical	Actionable	In a preclinical study, BAY1125976 demonstrated anti-tumor efficacy in multiple xenograft tumor models of different cancers with PIK3CA mutations or PTEN deletions and displayed synergy with other anti-cancer therapies (Cancer Res 2013;73(8 Suppl):Abstract nr 2050).	detail...

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT01915576	Phase I	BAY1125976	Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients	Completed	USA \| FRA \| DEU \| CHE	0

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