Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by industry and academic entities—including Corvus Pharmaceuticals, M.D. Anderson Cancer Center, and Hoffmann-La Roche—evaluate Ciforadenant across healthy volunteers and diverse oncological indications. These studies assess Ciforadenant as monotherapy and combination therapy for conditions such as renal cell carcinoma, non-small cell lung cancer, metastatic castration-resistant prostate cancer, and relapsed or refractory multiple myeloma. Spanning completed, active non-recruiting, and terminated statuses, these protocols evaluate the pharmacokinetics, safety, and preliminary efficacy of targeted adenosine A2A receptor blockade.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05501054 ACTIVE_NOT_RECRUITING
Renal Cell Carcinoma
M.D. Anderson Cancer Center
 2023-02-09 PHASE1; PHASE2
NCT03337698 TERMINATED
Carcinoma, Non-Small-Cell Lung
Hoffmann-La Roche
 2017-12-27 PHASE1; PHASE2
NCT03454451 COMPLETED
Non-Small Cell Lung Cancer; Renal Cell Cancer; Colorectal Cancer; Triple Negative Breast Cancer; Cervical Cancer; Ovarian Cancer; Pancreatic Cancer; Endometrial Cancer; Sarcoma; Squamous Cell Carcinoma of the Head and Neck; Bladder Cancer; Metastatic Castration Resistant Prostate Cancer; Non-hodgkin Lymphoma
Corvus Pharmaceuticals, Inc.
 2018-04-25 PHASE1
NCT04280328 COMPLETED
Multiple Myeloma
Corvus Pharmaceuticals, Inc.
 2020-02-20 PHASE1
NCT02655822 COMPLETED
Renal Cell Cancer; Metastatic Castration Resistant Prostate Cancer
Corvus Pharmaceuticals, Inc.
 2016-01 PHASE1
NCT03237988 COMPLETED
Healthy Subjects
Corvus Pharmaceuticals, Inc.
 2017-07-20 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-16)

Check the Ciforadenant (CPI-444) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ciforadenant selectively binds to the adenosine A2A receptor, thereby blocking extracellular adenosine-induced intracellular cyclic AMP signaling and reversing immune cell suppression within the tumor microenvironment. This inhibition restores T-lymphocyte and natural killer cell cytotoxicity, promoting systemic anti-tumor immunity to limit disease progression in clinical conditions including renal cell carcinoma and non-small cell lung 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>).

Jump to

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