AOH1996 Clinical Trials

Size	Price	Qty
5mg	USD 179
25mg	USD 537

Clinical Trials

Multiple clinical trials sponsored by the City of Hope Medical Center are actively recruiting participants to evaluate AOH1996. These Phase 1 studies assess the safety, tolerability, and preliminary activity of the agent across diverse malignancies, including refractory acute myeloid leukemia, advanced solid neoplasms, osteosarcoma, leiomyosarcomas, synovial sarcomas, ovarian cancer, non-small cell lung cancer, and pancreatic cancer. Together, these trials represent early-stage clinical development exploring the therapeutic utility of PCNA inhibition in oncology settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05227326	RECRUITING	Refractory Malignant Solid Neoplasm; Osteosarcoma; Leiomyosarcomas; Synovial Sarcomas; Ovarian Cancer; Non-Small Cell Lung Cancer; Pancreatic Cancer	City of Hope Medical Center	2022-08-12	PHASE1
NCT06763341	RECRUITING	Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	City of Hope Medical Center	2025-07-30	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-28)

Check the AOH1996 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AOH1996 functions as a small-molecule inhibitor that selectively targets proliferating cell nuclear antigen (PCNA) and enhances its interaction with RPB1, the largest subunit of RNA polymerase II, thereby disrupting transcription-replication machinery and causing genomic instability. Consequently, this mechanism induces selective DNA replication stress and apoptosis in malignant cells, providing a rationale for evaluating AOH1996 in clinical trials for refractory solid tumors and acute myeloid leukemia.

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>).