Therapy Detail

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Therapy Name Sapanisertib
Synonyms
Therapy Description

Sapanisertib (MLN0128) is an ATP-competitive mTOR kinase inhibitor that induces apoptosis and inhibits growth in tumor cells (PMID: 25519700).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sapanisertib INK128|INK-128|TAK-228|MLN0128|MLN-0128 mTOR Inhibitor 51 Sapanisertib (MLN0128) is an ATP-competitive mTOR kinase inhibitor that induces apoptosis and inhibits growth in tumor cells (PMID: 25519700, PMID: 32488989).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
TSC1 inact mut transitional cell carcinoma no benefit Sapanisertib Phase II Actionable In a Phase II trial, treatment with Sapanisertib (MLN0128) in metastatic urothelial carcinoma patients with either a TSC1 or TSC2 activating mutation (n=13) did not result in an objective response and led to a median overall survival of 3.4 months, and the trial was terminated early due to limited clinical activity and poor drug tolerability (Journal of Clinical Oncology 39, no. 6_suppl (February 20, 2021) 431-431; NCT03047213). detail...
CDKN2A mut PIK3CA mut breast cancer sensitive Sapanisertib Preclinical Actionable In a preclinical study, a breast cancer cell line harboring mutations in PIK3CA and CDKN2A demonstrated sensitivity to Sapanisertib (MLN0128) in culture (PMID: 25261369). 25261369
PTEN mutant breast cancer sensitive Sapanisertib Preclinical Actionable In a preclinical study, Sapanisertib (MLN0128) induced apoptosis and inhibited MTORC1 signaling in breast cancer cells harboring a PTEN mutation (PMID: 25261369). 25261369
PIK3CA mutant breast cancer sensitive Sapanisertib Preclinical Actionable In a preclinical study, Sapanisertib (MLN0128) demonstrated efficacy in PIK3CA mutant breast cancer xenograft models (PMID: 23085766). 23085766
PIK3CA mutant Advanced Solid Tumor sensitive Sapanisertib Preclinical Actionable In a preclinical study, human cancer cell lines harboring PIK3CA mutations were sensitive to Sapanisertib (MLN0128) as demonstrated by significant growth inhibition (PMID: 25261369). 25261369
TSC2 inact mut transitional cell carcinoma no benefit Sapanisertib Phase II Actionable In a Phase II trial, treatment with Sapanisertib (MLN0128) in metastatic urothelial carcinoma patients with either a TSC1 or TSC2 activating mutation (n=13) did not result in an objective response and led to a median overall survival of 3.4 months, and the trial was terminated early due to limited clinical activity and poor drug tolerability (Journal of Clinical Oncology 39, no. 6_suppl (February 20, 2021) 431-431; NCT03047213). detail...
PTEN mut TP53 mut skin cancer sensitive Sapanisertib Preclinical Actionable In a preclinical study, a skin cancer cell line harboring mutations in PTEN and TP53 demonstrated sensitivity to Sapanisertib (MLN0128) in culture (PMID: 25261369). 25261369

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05275673 Phase II Sapanisertib A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer Recruiting USA 0
NCT02619669 Phase I Sapanisertib Letrozole Neoadjuvant Run-In Study With TAK-228 (MLN0128) Followed by Letrozole/TAK-228 (MLN0128) in Women With High-Risk ER+/HER2- Breast Cancer Withdrawn USA 0
NCT02724020 Phase II Sapanisertib + Serabelisib Sapanisertib Everolimus MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Completed USA | ITA | FRA | ESP | CAN 3
NCT02514824 Phase Ib/II Sapanisertib MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma Completed USA 0
NCT02601209 Phase Ib/II Pazopanib Sapanisertib Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma Terminated USA 0
NCT02725268 Phase II Paclitaxel Sapanisertib Sapanisertib + Serabelisib Phase 2 Study of MLN0128, Combination of MLN0128 With MLN1117, Paclitaxel and Combination of MLN0128 With Paclitaxel in Women With Endometrial Cancer Completed USA | ITA | ESP | DEU | CAN | BEL 4
NCT03097328 Phase II Sapanisertib Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma Active, not recruiting USA 0
NCT01058707 Phase I Sapanisertib Dose Escalation Study of MLN0128 in Subjects With Advanced Malignancies Completed USA | ESP 0
NCT02893930 Phase II Sapanisertib Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery Active, not recruiting USA 0
NCT02987959 Phase II Sapanisertib Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas Terminated USA 0
NCT02133183 Phase I Sapanisertib TORC1/2 Inhibitor INK128 Before and After Surgery in Treating Patients With Recurrent Glioblastoma Active, not recruiting USA 0
NCT02484430 Phase II Sapanisertib TORC1/2 Inhibitor INK128 in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia Active, not recruiting USA 0
NCT02244463 Phase II Sapanisertib A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer Active, not recruiting USA 0
NCT03047213 Phase II Sapanisertib Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations Active, not recruiting USA 0
NCT02412722 Phase I Sapanisertib Paclitaxel Safety, Tolerability, and Pharmacokinetics of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies Completed USA 0
NCT02197572 Phase I Sapanisertib Effect of MLN0128 on the QTc Interval in Participants With Advanced Solid Tumors Completed USA 0
NCT02417701 Phase II Sapanisertib Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer Completed USA 0
NCT02091531 Phase II Sapanisertib Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients Completed USA 0
NCT02575339 Phase Ib/II Sorafenib Sapanisertib MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma Terminated USA 0


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