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Therapy Name	Serabelisib
Synonyms
Therapy Description	Serabelisib (MLN1117) selectively inhibits PI3K alpha kinase, including mutations of PIK3CA, and therefore, targets the PI3K/Akt/mTOR pathway with potentially less toxicity than pan-PI3K inhibitors (PMID: 28490463, PMID: 30168905).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Serabelisib		INK1117\|TAK-117\|MLN-1117\|MLN1117	PIK3CA inhibitor 26	Serabelisib (MLN1117) selectively inhibits PI3K alpha kinase, including mutations of PIK3CA, and therefore, targets the PI3K/Akt/mTOR pathway with potentially less toxicity than pan-PI3K inhibitors (PMID: 28490463, PMID: 30168905).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
PIK3CA mutant	Advanced Solid Tumor	sensitive	Serabelisib	Phase I	Actionable	In a Phase I trial, MLN1117 demonstrated safety and preliminary efficacy in a variety of patients with advanced solid tumors carrying PIK3CA mutations (Journal of Clinical Oncology, 2015 ASCO Annual Meeting Vol 33, No 15_suppl., 2015: 2501).	detail...
PIK3CA mutant	stomach cancer	predicted - sensitive	Serabelisib	Case Reports/Case Series	Actionable	In a Phase I trial, MLN1117 (INK1117) treatment resulted in a partial response in one patient with gastric cancer harboring a PIK3CA mutation (PMID: 28490463; NCT01449370).	28490463
PIK3CA mutant	breast cancer	predicted - sensitive	Serabelisib	Case Reports/Case Series	Actionable	In a Phase I trial, MLN1117 (INK1117) treatment resulted in partial response in 3 patients with breast cancer harboring PI3CA mutations (PMID: 28490463; NCT01449370).	28490463
PIK3CA mutant	Advanced Solid Tumor	sensitive	Serabelisib	Preclinical	Actionable	In a preclinical study, MLN1117 inhibited proliferation of tumor cells harboring oncogenic PIK3CA mutations in culture and inhibited tumor growth in PIK3CA mutant xenograft models (Cancer Ther 2011;10(11 Suppl):Abstract nr A171).	detail...

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT05300048	Phase I	Serabelisib Nab-paclitaxel + Serabelisib	Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations	Active, not recruiting	USA	0
NCT01449370	Phase I	Serabelisib	Dose Escalation Study of MLN1117 in Subjects With Advanced Cancer	Completed	USA \| GBR \| ESP	0
NCT02551055	Phase I	Docetaxel Paclitaxel Alisertib Mivavotinib Serabelisib	MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma	Terminated	USA \| ESP	0

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