Clinical Trials

Several Phase I and Phase II clinical trials evaluate the therapeutic profile and pharmacokinetics of Etrumadenant (AB928) in healthy participants and patients with advanced solid tumors, including non-small cell lung cancer, metastatic colorectal cancer, pancreatic ductal adenocarcinoma, and gastroesophageal malignancies. Supported by both industry sponsors and academic medical centers, these studies encompass recruitment statuses ranging from active recruitment to completed, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05633667 ACTIVE_NOT_RECRUITING
Lung Cancer; Advanced or Metastatic Non-Small-Cell Lung Cancer; Resectable Non-Small-Cell Lung Cancer
Gilead Sciences
 2023-03-16 PHASE2
NCT05335941 ACTIVE_NOT_RECRUITING
Urothelial Carcinoma; Metastatic Cancer
M.D. Anderson Cancer Center
 2023-06-13 PHASE2
NCT05886634 ACTIVE_NOT_RECRUITING
Dedifferentiated Liposarcoma; Soft Tissue Sarcoma; Sarcoma,Soft Tissue; Sarcoma; Recurrent Dedifferentiated Liposarcoma; Unresectable Dedifferentiated Liposarcoma; Metastatic Dedifferentiated Liposarcoma
Memorial Sloan Kettering Cancer Center
 2023-05-23 PHASE2
NCT03821246 RECRUITING
Prostate Adenocarcinoma; Prostate Cancer; Localized Prostate Cancer
David Oh
 2019-10-30 PHASE2
NCT06048484 RECRUITING
Pancreatic Ductal Adenocarcinoma
Gulam Manji
 2024-05-10 PHASE2
NCT05915442 RECRUITING
Oligometastatic Prostate Cancer
Catherine Spina
 2023-07-01 PHASE2
NCT05024097 RECRUITING
Rectal Cancer
Weill Medical College of Cornell University
 2022-03-31 PHASE2
NCT04791839 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer; Non-small Cell Carcinoma; Non-small Cell Lung Cancer
Washington University School of Medicine
 2021-08-04 PHASE2
NCT04892875 WITHDRAWN
Head and Neck Cancer; Squamous Cell Carcinoma of Head and Neck; Oral Cavity Squamous Cell Carcinoma; Oral Cavity Cancer; Oropharynx Cancer; Oropharynx Squamous Cell Carcinoma; Larynx Cancer; Pharynx Cancer; Hypopharynx Cancer; Hypopharynx Squamous Cell Carcinoma
Jennifer Choe
 2023-12-31 PHASE1
NCT04660812 COMPLETED
Metastatic Colorectal Cancer
Arcus Biosciences, Inc.
 2021-05-10 PHASE1; PHASE2
NCT04262856 COMPLETED
Non Small Cell Lung Cancer; Nonsquamous Non Small Cell Lung Cancer; Squamous Non Small Cell Lung Cancer; Lung Cancer
Arcus Biosciences, Inc.
 2020-05-28 PHASE2
NCT03193190 COMPLETED
Pancreatic Adenocarcinoma
Hoffmann-La Roche
 2017-07-05 PHASE1; PHASE2
NCT03846310 COMPLETED
Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer; Nonsquamous Nonsmall Cell Neoplasm of Lung; Sensitizing EGFR Gene Mutation
Arcus Biosciences, Inc.
 2019-04-01 PHASE1
NCT04381832 COMPLETED
Prostatic Neoplasms, Castration-Resistant; Androgen-Resistant Prostatic Neoplasms; Castration Resistant Prostatic Neoplasms; Prostatic Cancer, Castration-Resistant
Arcus Biosciences, Inc.
 2020-07-07 PHASE1; PHASE2
NCT05177770 TERMINATED
Metastatic Castration-resistant Prostate Cancer; Prostate Cancer
Coherus Oncology, Inc.
 2022-01-17 PHASE2
NCT03555149 TERMINATED
Colorectal Cancer
Hoffmann-La Roche
 2018-09-27 PHASE1; PHASE2
NCT05411146 COMPLETED
Healthy Participants
Arcus Biosciences, Inc.
 2022-05-25 PHASE1
NCT05277012 COMPLETED
Healthy Participants
Arcus Biosciences, Inc.
 2022-02-10 PHASE1
NCT05154136 COMPLETED
Healthy Participants
Arcus Biosciences, Inc.
 2021-10-20 PHASE1
NCT03629756 COMPLETED
Non-small Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck; Breast Cancer; Colorectal Cancer; Melanoma; Bladder Cancer; Ovarian Cancer; Endometrial Cancer; Merkel Cell Carcinoma; GastroEsophageal Cancer; Renal Cell Carcinoma; Castration-resistant Prostate Cancer
Arcus Biosciences, Inc.
 2018-07-24 PHASE1
NCT03719326 COMPLETED
TNBC - Triple-Negative Breast Cancer; Ovarian Cancer
Arcus Biosciences, Inc.
 2018-10-15 PHASE1
NCT03720678 COMPLETED
GastroEsophageal Cancer; Colorectal Cancer
Arcus Biosciences, Inc.
 2018-11-18 PHASE1
NCT03720678 Completed
GastroEsophageal Cancer|Colorectal Cancer
Arcus Biosciences Inc.
 2018-11-18 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-01)

Check the Etrumadenant (AB928) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Etrumadenant selectively binds to adenosine A2a and A2b receptors with Kd values of 1.4 nM and 2 nM, respectively, blocking adenosine-mediated cAMP accumulation and reversing immunosuppression within the tumor microenvironment. By restoring immune cell effector function and promoting anti-tumor immune responses, this dual receptor antagonism suppresses tumor growth and immune evasion in malignancies such as non-small cell lung cancer and colorectal cancer.

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>).

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Note: Technical data last updated: Sep 1, 2026.