Sapanisertib (MLN0128, INK-128) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Sapanisertib (MLN0128) has been evaluated in numerous clinical trials as a single agent or in combination regimens for advanced malignancies, including non-small cell lung cancer, hepatocellular carcinoma, endometrial cancer, glioblastoma, and metastatic breast carcinoma. These early-phase protocols—sponsored by academic institutions like M.D. Anderson Cancer Center, federal entities such as the National Cancer Institute, and pharmaceutical companies including Millennium Pharmaceuticals and Faeth Therapeutics—encompass active, recruiting, completed, active not recruiting, and terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07558733	RECRUITING	HR+ HER2- Breast Cancer	Faeth Therapeutics	2026-04-22	PHASE1; PHASE2
NCT06463028	RECRUITING	Endometrial Cancer	Faeth Therapeutics	2024-12-12	PHASE2
NCT06811116	RECRUITING	Advanced Hepatocellular Carcinoma; Metastatic Hepatocellular Carcinoma; Stage III Hepatocellular Carcinoma AJCC v8; Stage IV Hepatocellular Carcinoma AJCC v8	National Cancer Institute (NCI)	2025-11-17	PHASE1; PHASE2
NCT02503722	ACTIVE_NOT_RECRUITING	Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage III Lung Non-Small Cell Cancer AJCC v7; Stage IIIA Lung Non-Small Cell Cancer AJCC v7; Stage IIIB Lung Non-Small Cell Cancer AJCC v7; Stage IV Lung Non-Small Cell Cancer AJCC v7	National Cancer Institute (NCI)	2017-03-23	PHASE1
NCT02465060	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma	National Cancer Institute (NCI)	2015-08-17	PHASE2
NCT06390865	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma	National Cancer Institute (NCI)	2017-03-12	PHASE2
NCT06385496	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma	National Cancer Institute (NCI)	2017-03-12	PHASE2
NCT04250545	ACTIVE_NOT_RECRUITING	Leptomeningeal Neoplasm; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Malignant Neoplasm in the Brain; Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	National Cancer Institute (NCI)	2020-10-26	PHASE1
NCT04267913	WITHDRAWN	Lung Squamous Cell Carcinoma; Recurrent Lung Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	SWOG Cancer Research Network	2020-09-05	PHASE2
NCT04479306	COMPLETED	Recurrent Lung Non-Small Cell Carcinoma; Stage IIIB Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	M.D. Anderson Cancer Center	2020-06-18	PHASE1
NCT05275673	TERMINATED	Non-Small Cell Lung Cancer; Squamous Non-small-cell Lung Cancer; Squamous Non-Small Cell Neoplasm of Lung; NFE2L2 Gene Mutation	Faeth Therapeutics	2022-07-21	PHASE2
NCT03017833	COMPLETED	Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Refractory Neoplasm	M.D. Anderson Cancer Center	2018-03-12	PHASE1
NCT03430882	COMPLETED	Recurrent Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm	M.D. Anderson Cancer Center	2018-03-12	PHASE1
NCT02244463	COMPLETED	Anaplastic Thyroid Cancer; Thyroid Cancer; Differentiated Thyroid Cancer	Dana-Farber Cancer Institute	2015-07	PHASE1; PHASE2
NCT02159989	COMPLETED	Advanced Malignant Solid Neoplasm; Fibrolamellar Carcinoma; Metastatic Malignant Solid Neoplasm; Ovarian Carcinoma; Pancreatic Neuroendocrine Tumor; Recurrent Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Unresectable Solid Neoplasm	National Cancer Institute (NCI)	2014-06-18	PHASE1
NCT02893930	COMPLETED	Pancreatic Neuroendocrine Tumor G1; Pancreatic Neuroendocrine Tumor G2; Refractory Pancreatic Neuroendocrine Carcinoma	National Cancer Institute (NCI)	2017-04-28	PHASE2
NCT05022394	WITHDRAWN	Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Stage I Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	M.D. Anderson Cancer Center	2021-02-18	PHASE1; PHASE2
NCT02142803	ACTIVE_NOT_RECRUITING	Adult Glioblastoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Solid Neoplasm; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIIA Ovarian Cancer AJCC v6 and v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage IIIB Fallopian Tube Cancer AJCC v7; Stage IIIB Ovarian Cancer AJCC v6 and v7; Stage IIIB Primary Peritoneal Cancer AJCC v7; Stage IIIC Fallopian Tube Cancer AJCC v7; Stage IIIC Ovarian Cancer AJCC v6 and v7; Stage IIIC Primary Peritoneal Cancer AJCC v7; Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7	National Cancer Institute (NCI)	2014-05-20	PHASE1
NCT02417701	COMPLETED	Recurrent Lung Squamous Cell Carcinoma; Stage IV Lung Squamous Cell Carcinoma AJCC v7	National Cancer Institute (NCI)	2016-10-06	PHASE2
NCT03047213	ACTIVE_NOT_RECRUITING	Locally Advanced Bladder Urothelial Carcinoma; Metastatic Transitional Cell Carcinoma; Metastatic Urothelial Carcinoma; Recurrent Bladder Carcinoma; Stage III Bladder Urothelial Carcinoma AJCC v6 and v7; Stage IV Bladder Urothelial Carcinoma AJCC v7	National Cancer Institute (NCI)	2017-08-24	PHASE2
NCT04250545	Recruiting	Leptomeningeal Neoplasm\|Metastatic Lung Non-Small Cell Carcinoma\|Metastatic Malignant Neoplasm in the Brain\|Recurrent Lung Non-Small Cell Carcinoma\|Stage IV Lung Cancer AJCC v8\|Stage IVA Lung Cancer AJCC v8\|Stage IVB Lung Cancer AJCC v8	National Cancer Institute (NCI)	2020-10-26	Phase 1
NCT02719691	COMPLETED	Metastatic Breast Cancer; Solid Tumors	University of Colorado, Denver	2016-05-13	PHASE1
NCT02724020	COMPLETED	Clear-cell Metastatic Renal Cell Carcinoma	Millennium Pharmaceuticals, Inc.	2016-06-30	PHASE2
NCT02133183	TERMINATED	Glioblastoma; Gliosarcoma	National Cancer Institute (NCI)	2014-07-02	PHASE1
NCT02756364	COMPLETED	Breast Neoplasms	Calithera Biosciences, Inc	2016-07-28	PHASE2
NCT02725268	COMPLETED	Endometrial Neoplasms	Millennium Pharmaceuticals, Inc.	2016-04-01	PHASE2
NCT01058707	COMPLETED	Advanced Solid Malignancies	Millennium Pharmaceuticals, Inc.	2010-01-04	PHASE1
NCT02987959	TERMINATED	Soft-tissue Sarcoma	Fox Chase Cancer Center	2017-02-21	PHASE2
NCT02484430	COMPLETED	B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; Recurrent Adult Acute Lymphoblastic Leukemia; Refractory Adult Acute Lymphoblastic Leukemia; T Acute Lymphoblastic Leukemia	National Cancer Institute (NCI)	2017-04-06	PHASE2
NCT02601209	TERMINATED	High Grade Sarcoma; Metastatic Leiomyosarcoma; Metastatic Malignant Peripheral Nerve Sheath Tumor; Metastatic Synovial Sarcoma; Metastatic Undifferentiated Pleomorphic Sarcoma; Metastatic Unresectable Sarcoma; Myxofibrosarcoma; Recurrent Leiomyosarcoma; Recurrent Malignant Peripheral Nerve Sheath Tumor; Recurrent Synovial Sarcoma; Recurrent Undifferentiated Pleomorphic Sarcoma; Stage III Uterine Corpus Leiomyosarcoma AJCC v8; Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8; Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8; Stage IIIC Uterine Corpus Leiomyosarcoma AJCC v8; Stage IV Uterine Corpus Leiomyosarcoma AJCC v8; Stage IVA Uterine Corpus Leiomyosarcoma AJCC v8; Stage IVB Uterine Corpus Leiomyosarcoma AJCC v8; Unresectable Leiomyosarcoma	National Cancer Institute (NCI)	2015-11-30	PHASE1; PHASE2
NCT02091531	COMPLETED	Metastatic Castration-Resistant Prostate Cancer	Memorial Sloan Kettering Cancer Center	2014-03	PHASE2
NCT02327169	COMPLETED	Advanced Nonhematologic Malignancies	Millennium Pharmaceuticals, Inc.	2015-01-14	PHASE1
NCT02049957	COMPLETED	Breast Cancer	Calithera Biosciences, Inc	2014-02-13	PHASE2
NCT02575339	TERMINATED	Hepatocellular Carcinoma; Liver Cancer; HCC	Kathy Miller	2016-07-18	PHASE1; PHASE2
NCT02412722	COMPLETED	Non-hematologic Malignancy	Millennium Pharmaceuticals, Inc.	2015-03-26	PHASE1
NCT01351350	COMPLETED	Advanced Solid Malignancies; Hematologic Malignancies	Millennium Pharmaceuticals, Inc.	2011-02-28	PHASE1
NCT02514824	COMPLETED	Merkel Cell Carcinoma	Dana-Farber Cancer Institute	2015-10	PHASE1; PHASE2
NCT01899053	COMPLETED	Advanced Nonhematologic Malignancies	Millennium Pharmaceuticals, Inc.	2013-06-28	PHASE1
NCT02575339	Terminated	Hepatocellular Carcinoma\|Liver Cancer\|HCC	Kathy Miller\|Millennium Pharmaceuticals Inc.\|Big Ten Cancer Research Consortium	2016-07-18	Phase 1\|Phase 2
NCT02197572	COMPLETED	Advanced Solid Tumors	Calithera Biosciences, Inc	2014-09-15	PHASE1
NCT02719691	Completed	Metastatic Breast Cancer\|Solid Tumors	University of Colorado Denver	2016-05-13	Phase 1
NCT02514824	Completed	Merkel Cell Carcinoma	Dana-Farber Cancer Institute\|Millennium Pharmaceuticals Inc.	2015-10	Phase 1\|Phase 2
NCT01118689	COMPLETED	Relapsed Multiple Myeloma; Refractory Multiple Myeloma; Waldenstrom Macroglobulinemia	Millennium Pharmaceuticals, Inc.	2010-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-02)

Check the Sapanisertib (MLN0128, INK-128) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sapanisertib acts as a potent ATP-competitive inhibitor of mammalian target of rapamycin, selectively binding and blocking both the mTORC1 and mTORC2 signaling complexes with a nanomolar half-maximal inhibitory concentration. This dual inhibition prevents downstream substrate phosphorylation and protein translation, driving cell cycle arrest and suppressing tumor progression in clinical conditions such as non-small cell lung cancer and endometrial carcinoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).