HRO761 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A Phase 1 open-label clinical trial sponsored by Novartis Pharmaceuticals is evaluating the safety, tolerability, and dosing of HRO761 as a monotherapy and in combination regimens. The study focuses on patients with advanced unresectable or metastatic solid tumors, including colorectal cancers, exhibiting microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) phenotypes. The trial is currently designated as active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05838768	ACTIVE_NOT_RECRUITING	MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers	Novartis Pharmaceuticals	2023-06-27	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-24)

Check the HRO761 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

HRO761 functions as a potent and selective allosteric inhibitor that binds at the interface of the D1 and D2 helicase domains of Werner syndrome RecQ helicase (WRN), locking the enzyme into an inactive conformation and preventing its downstream catalytic activity. By suppressing WRN function, HRO761 induces targeted anti-proliferative effects in cancer cells, demonstrating clinical relevance for treating microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) advanced unresectable or metastatic solid tumors, including colorectal 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>).