Zedoresertib (Debio-0123, WEE1-IN-5) Clinical Trials

Size	Price	Qty
5mg	USD 319
25mg	USD 957

Clinical Trials

Multiple Phase I, I/II, and II clinical trials evaluate zedoresertib (Debio-0123) as monotherapy or combination therapy across indications including advanced solid tumors, recurrent small cell lung cancer, IDH-wildtype glioblastoma, grade III astrocytoma, and advanced breast cancer. Sponsored by pharmaceutical entities and trial organizations such as Debiopharm International SA, Repare Therapeutics, and MedSIR, these studies exhibit varied recruitment statuses, including recruiting, active not recruiting, and terminated. Overall, these clinical investigations aim to establish the safety, pharmacokinetics, and preliminary efficacy of zedoresertib in challenging oncological settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05765812	RECRUITING	Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype; Astrocytoma, Grade III	Debiopharm International SA	2023-05-15	PHASE1; PHASE2
NCT04855656	RECRUITING	Advanced Solid Tumor	Debiopharm International SA	2021-04-30	PHASE1
NCT06612203	ACTIVE_NOT_RECRUITING	Advanced Breast Cancer	MedSIR	2025-01-17	PHASE1; PHASE2
NCT05109975	TERMINATED	Advanced Solid Tumors	Debiopharm International SA	2021-11-05	PHASE1
NCT05815160	TERMINATED	Small Cell Lung Cancer Recurrent	Debiopharm International SA	2023-05-02	PHASE1
NCT03968653	TERMINATED	Advanced Solid Tumors	Debiopharm International SA	2019-07-30	PHASE1
NCT05815160	Recruiting	Small Cell Lung Cancer Recurrent	Debiopharm International SA	2023-05-02	Phase 1
NCT05765812	Recruiting	Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype\|Astrocytoma Grade III	Debiopharm International SA	2023-05-15	Phase 1\|Phase 2
NCT05109975	Recruiting	Advanced Solid Tumors	Debiopharm International SA	2021-11-05	Phase 1
NCT04855656	Recruiting	Advanced Solid Tumor	Repare Therapeutics\|Debiopharm International SA	2021-04-30	Phase 1
NCT03968653	Recruiting	Advanced Solid Tumors	Debiopharm International SA	2019-07-30	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the Zedoresertib (Debio-0123, WEE1-IN-5) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zedoresertib selectively binds to and inhibits the protein kinase Wee1, thereby blocking downstream phosphorylation of CDC2 and abrogating the G2 DNA damage cell cycle checkpoint. This checkpoint disruption forces tumor cells with un-repaired DNA damage into premature mitosis, inducing mitotic catastrophe and apoptotic cell death, which provides the rationale for its clinical evaluation in advanced solid tumors, glioblastoma, and lung cancers.

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>).