AB680 Clinical Trials

Size	Price	Qty
1mg	USD 190
5mg	USD 570

Clinical Trials

Multiple clinical trials evaluate the development landscape of AB680 (quemliclustat), progressing from completed Phase 1 safety, tolerability, and pharmacokinetic studies in healthy volunteers to Phase 1 and Phase 2 evaluations in gastrointestinal and solid malignancies, including advanced pancreatic cancer, metastatic colorectal cancer, oligometastatic prostate cancer, and biliary tract carcinomas such as cholangiocarcinoma. Sponsored by industry entities like Arcus Biosciences, Inc. alongside academic investigators including Catherine Spina and Nataliya Uboha, these studies display recruitment statuses ranging from completed to recruiting and active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04104672	ACTIVE_NOT_RECRUITING	Advanced Pancreatic Cancer	Arcus Biosciences, Inc.	2019-11-06	PHASE1
NCT05915442	RECRUITING	Oligometastatic Prostate Cancer	Catherine Spina	2023-07-01	PHASE2
NCT06048133	ACTIVE_NOT_RECRUITING	Biliary Tract Carcinoma; Cholangiocarcinoma; Bile Duct Cancer	Nataliya Uboha	2024-03-08	PHASE2
NCT04660812	COMPLETED	Metastatic Colorectal Cancer	Arcus Biosciences, Inc.	2021-05-10	PHASE1; PHASE2
NCT04575311	COMPLETED	Healthy Volunteers	Arcus Biosciences, Inc.	2020-10-20	PHASE1
NCT04575311	Completed	Healthy Volunteers	Arcus Biosciences Inc.	2020-10-20	Phase 1
NCT03677973	COMPLETED	Healthy Volunteers	Arcus Biosciences, Inc.	2018-10-16	PHASE1
NCT03677973	Completed	Healthy Volunteers	Arcus Biosciences Inc.	2018-10-16	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-07-02)

Check the AB680 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AB-680 acts as a potent, reversible, and selective inhibitor of ecto-5'-nucleotidase (CD73) with an inhibition constant (Ki) of 4.9 pM, effectively blocking the enzymatic breakdown of extracellular adenosine monophosphate (AMP) into immunosuppressive adenosine. By preventing adenosine accumulation and thereby relieving immune suppression to reactivate cytotoxic lymphocyte function, this mechanism aims to inhibit tumor growth in clinical settings such as pancreatic, colorectal, prostate, and biliary tract 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>).