Tersolisib (STX-478) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple early-phase clinical trials are evaluating tersolisib (STX-478). A completed Phase 1 study, sponsored by Scorpion Therapeutics (a subsidiary of Eli Lilly and Company), evaluated the compound's absorption, metabolism, and excretion in healthy male volunteers. Additionally, an ongoing Phase 1/2 trial sponsored by Eli Lilly and Company is actively recruiting participants to assess STX-478 as monotherapy and in combination regimens for patients with breast cancer and advanced adult solid tumors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05768139	RECRUITING	Breast Cancer; Solid Tumors, Adult	Eli Lilly and Company	2023-04-17	PHASE1; PHASE2
NCT06901336	COMPLETED	Healthy	Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company	2025-03-20	PHASE1

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

Check the Tersolisib (STX-478) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tersolisib (STX-478) functions as a mutant-selective allosteric inhibitor that selectively binds to mutated PI3Kα isoforms, thereby blocking downstream phosphoinositide 3-kinase/AKT signaling cascades and suppressing oncogenic cell proliferation. This targeted inhibition leads to tumor growth arrest and regression, offering therapeutic relevance for patients with PI3Kα-mutated advanced solid tumors and breast cancer.

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>).