Samuraciclib (ICEC0942) hydrochloride Clinical Trials

Size	Price	Qty
2mg	USD 177
5mg	USD 357

Clinical Trials

Multiple clinical trials spanning Phase 1, Phase 1b, and Phase 2 are evaluating samuraciclib and its combination regimens, with recruitment statuses ranging from not yet recruiting to active and completed. These investigations focus on advanced solid tumors, specifically hormone receptor-positive or metastatic breast cancer and pancreatic ductal adenocarcinoma across metastatic, resectable, and locally advanced stages. The studies are supported by pharmaceutical sponsors including Carrick Therapeutics, Pfizer, and Hoffmann-La Roche, alongside academic institutions such as the University Health Network, Toronto, and the University of Washington.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04802759	RECRUITING	Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer	Hoffmann-La Roche	2021-06-22	PHASE1; PHASE2
NCT07665684	NOT_YET_RECRUITING	Pancreas Ductal Adenocarcinoma; Pancreas Cancer, Metastatic; Pancreatic Adenocarcinoma Metastatic; Adenosquamous Carcinoma of the Pancreas; Mucinous Adenocarcinoma	University Health Network, Toronto	2026-07	PHASE1; PHASE2
NCT07645651	RECRUITING	Resectable Pancreatic Ductal Adenocarcinoma; Borderline Resectable Pancreatic Ductal Adenocarcinoma; Locally Advanced Pancreatic Ductal Adenocarcinoma	University of Washington	2026-09-15	PHASE1
NCT06125522	ACTIVE_NOT_RECRUITING	Breast Cancer	Pfizer	2024-01-10	PHASE1; PHASE2
NCT05963997	COMPLETED	Metastatic Breast Cancer; Locally Advanced Breast Cancer; Breast Cancer	Carrick Therapeutics Limited	2023-10-09	PHASE1; PHASE2
NCT05963984	COMPLETED	Metastatic Breast Cancer; Locally Advanced Breast Cancer; Breast Cancer	Carrick Therapeutics Limited	2023-11-16	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Samuraciclib (ICEC0942) hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Samuraciclib is a selective CDK7 inhibitor that directly binds cyclin-dependent kinase 7 to block downstream transcriptional machinery phosphorylation, thereby inhibiting transcription and driving cell cycle arrest and apoptosis. By suppressing tumor cell proliferation through targeted transcriptional and cell cycle inhibition, samuraciclib demonstrates therapeutic potential in clinical conditions including metastatic breast cancer and pancreatic ductal adenocarcinoma.

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>).