Clinical Trials

GSK2636771 has been evaluated in several clinical trials as both monotherapy and combination therapy with agents such as pembrolizumab or enzalutamide for PTEN-deficient malignancies, including metastatic melanoma, refractory lymphomas, and advanced solid tumors. Sponsored by GlaxoSmithKline alongside academic and federal institutions like the National Cancer Institute, M.D. Anderson Cancer Center, and Yonsei University, these early-phase evaluations encompass completed safety protocols as well as active, non-recruiting trials within initiatives like NCI-MATCH.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
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
NCT03131908 COMPLETED
Melanoma and Other Malignant Neoplasms of Skin; Metastatic Melanoma
M.D. Anderson Cancer Center
 2017-07-17 PHASE1; PHASE2
NCT02615730 COMPLETED
Advanced Gastric Adenocarcinoma
Yonsei University
 2016-02 PHASE1; PHASE2
NCT04439149 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2016-05-05 PHASE2
NCT04439188 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2016-03-21 PHASE2
NCT02215096 COMPLETED
Neoplasms
GlaxoSmithKline
 2014-11-13 PHASE1
NCT03131908 Active not recruiting
Melanoma and Other Malignant Neoplasms of Skin|Metastatic Melanoma
M.D. Anderson Cancer Center|National Cancer Institute (NCI)|National Institutes of Health (NIH)|Merck Sharp & Dohme LLC|GlaxoSmithKline
 2017-07-17 Phase 1|Phase 2
NCT01458067 COMPLETED
Cancer
GlaxoSmithKline
 2011-11-10 PHASE1
NCT02215096 Completed
Neoplasms
GlaxoSmithKline
 2014-11-13 Phase 1
NCT01458067 Completed
Cancer
GlaxoSmithKline
 2011-11-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the GSK2636771 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GSK2636771 selectively binds to and inhibits phosphoinositide 3-kinase beta (PI3Kβ), blocking downstream AKT serine/threonine kinase phosphorylation and suppressing oncogenic lipid signaling pathways essential for cellular survival and proliferation. By selectively arresting signal transduction in cells lacking functional PTEN, this compound induces apoptosis and inhibits tumor growth, providing a targeted therapeutic rationale for treating PTEN-deficient advanced solid tumors and refractory hematologic malignancies evaluated in clinical trials.

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>).

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Note: Technical data last updated: Sep 1, 2026.