Samotolisib (LY3023414) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple clinical trials spanning Phase I and Phase II have evaluated samotolisib monotherapy and combination regimens in healthy volunteers, advanced solid tumors, metastatic breast cancer, non-small cell lung cancer, and pediatric malignancies like osteosarcoma and Ewing sarcoma. Sponsored by industry, government, and academic entities—including Eli Lilly and Company, the National Cancer Institute, and Dana-Farber Cancer Institute—these studies encompass completed, active not recruiting, and terminated recruitment statuses. Collectively, these investigations demonstrate extensive evaluation of samotolisib's pharmacokinetic profile and therapeutic efficacy across diverse adult and pediatric cancers.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03675893	RECRUITING	Endometrial Cancer	Dana-Farber Cancer Institute	2018-12-24	PHASE2
NCT03155620	ACTIVE_NOT_RECRUITING	Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor	National Cancer Institute (NCI)	2017-07-31	PHASE2
NCT03213678	COMPLETED	Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Malignant Glioma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Central Nervous System Neoplasm; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor	National Cancer Institute (NCI)	2017-11-28	PHASE2
NCT04032080	COMPLETED	Triple Negative Breast Cancer	Baylor Research Institute	2019-09-05	PHASE2
NCT02549989	COMPLETED	Endometrial Cancer; Recurrent Endometrial Cancer	Memorial Sloan Kettering Cancer Center	2015-09	PHASE2
NCT02057133	ACTIVE_NOT_RECRUITING	Breast Neoplasms	Eli Lilly and Company	2014-03-10	PHASE1
NCT02124148	COMPLETED	Neoplasm Metastasis; Colorectal Neoplasms; Breast Cancer	Eli Lilly and Company	2014-06-18	PHASE1
NCT01655225	COMPLETED	Advanced Cancer; Metastatic Cancer; Non-Hodgkin's Lymphoma; Metastatic Breast Cancer; Malignant Mesothelioma; Non-small Cell Lung Cancer	Eli Lilly and Company	2012-07-31	PHASE1
NCT02407054	COMPLETED	Prostate Cancer Metastatic	Eli Lilly and Company	2015-04-29	PHASE2
NCT02784795	TERMINATED	Solid Tumor; Breast Cancer; Colon Cancer; Cholangiocarcinoma; Soft Tissue Sarcoma	Eli Lilly and Company	2016-11-04	PHASE1
NCT02079636	COMPLETED	Carcinoma, Non-small Cell Lung	Eli Lilly and Company	2014-03-28	PHASE1
NCT02981342	COMPLETED	Pancreatic Ductal Adenocarcinoma	Eli Lilly and Company	2017-01-12	PHASE2
NCT02443337	TERMINATED	Non-small Cell Lung Cancer Metastatic	Eli Lilly and Company	2015-07	PHASE2
NCT02536586	COMPLETED	Neoplasm	Eli Lilly and Company	2015-09	PHASE1
NCT02818335	COMPLETED	Healthy	Eli Lilly and Company	2016-07	PHASE1
NCT02575703	COMPLETED	Healthy	Eli Lilly and Company	2015-10	PHASE1
NCT02575703	Completed	Healthy	Eli Lilly and Company	2015-10	Phase 1
NCT02536586	Completed	Neoplasm	Eli Lilly and Company	2015-09	Phase 1
NCT02443337	Terminated	Non-small Cell Lung Cancer Metastatic	Eli Lilly and Company\|SCRI Development Innovations LLC	2015-07	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-06-22)

Check the Samotolisib (LY3023414) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Samotolisib functions as an oral, ATP-competitive inhibitor targeting class I phosphoinositide 3-kinase (PI3K) isoforms, mammalian target of rapamycin (mTOR), and DNA-dependent protein kinase (DNA-PK), effectively blocking downstream Akt phosphorylation and signaling. This dual inhibition of survival pathways and DNA repair mechanisms arrests cell cycle progression and triggers apoptosis, suppressing tumor cell proliferation in clinical indications such as advanced solid tumors and refractory pediatric malignancies.

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>).