Clinical Trials

Evofosfamide (TH-302) has been evaluated in numerous clinical trials across early to late phases for treating pancreatic adenocarcinoma, castration-resistant prostate cancer, soft tissue sarcoma, multiple myeloma, and advanced solid tumors. Sponsored by pharmaceutical entities such as Threshold Pharmaceuticals and Merck KGaA alongside academic centers like the University Health Network, Toronto, trial statuses range from completed safety evaluations to actively recruiting combination immunotherapy protocols and planned mid-stage studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06836726 NOT_YET_RECRUITING
Castration Resistant Prostate Cancer
University Health Network, Toronto
 2026-05-27 PHASE2
NCT06782555 RECRUITING
Metastatic Prostate Cancer; Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Pancreatic Cancer
ImmunoGenesis
 2025-01-08 PHASE1; PHASE2
NCT02342379 COMPLETED
Glioblastoma
The University of Texas Health Science Center at San Antonio
 2015-05 PHASE2
NCT03098160 UNKNOWN
Pancreatic Cancer; Melanoma; Squamous Cell Carcinoma of the Head and Neck; Prostate Cancer
Threshold Pharmaceuticals
 2017-05-10 PHASE1
NCT02402062 COMPLETED
Neuroendocrine Tumors; Pancreatic Neoplasms
Grupo Espanol de Tumores Neuroendocrinos
 2015-05-11 PHASE2
NCT02433639 COMPLETED
Biliary Tract Cancer
Seoul National University Hospital
 2015-04 PHASE2
NCT01522872 UNKNOWN
Multiple Myeloma
Threshold Pharmaceuticals
 2012-02 PHASE1; PHASE2
NCT02020226 UNKNOWN
Solid Tumors
Threshold Pharmaceuticals
 2013-11 PHASE1
NCT02598687 WITHDRAWN
Esophageal Cancer
Maastricht Radiation Oncology
 2015-12 PHASE1
NCT02093962 TERMINATED
Non-small Cell Lung Cancer
ImmunoGenesis
 2014-06 PHASE2
NCT01746979 COMPLETED
Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
ImmunoGenesis
 2012-12 PHASE3
NCT02255110 TERMINATED
Soft Tissue Sarcoma
Merck KGaA, Darmstadt, Germany
 2014-12-10 PHASE2
NCT01497444 COMPLETED
Kidney Cancer; Liver Cancer
Alliance for Clinical Trials in Oncology
 2012-05 PHASE1
NCT01440088 COMPLETED
Soft Tissue Sarcoma
Threshold Pharmaceuticals
 2011-09 PHASE3
NCT01721941 UNKNOWN
Hepatocellular Carcinoma
Scripps Clinic Cancer Center
 2014-12 PHASE1
NCT01403610 COMPLETED
HIGH GRADE GLIOMA
The University of Texas Health Science Center at San Antonio
 2011-06 PHASE2
NCT02047500 TERMINATED
Pancreatic Cancer
ImmunoGenesis
 2014-01 PHASE1
NCT01864538 TERMINATED
Metastatic Melanoma
ImmunoGenesis
 2013-05 PHASE2
NCT01833546 COMPLETED
Solid Tumor; Pancreatic Cancer
Merck KGaA, Darmstadt, Germany
 2013-04-18 PHASE1
NCT02496832 WITHDRAWN
Pancreatic Adenocarcinoma; Advanced Disease; Metastatic Disease
University Health Network, Toronto
 2014-11
NCT02076230 COMPLETED
Solid Tumor
Merck KGaA, Darmstadt, Germany
 2014-02 PHASE1
NCT01381822 UNKNOWN
Advanced Renal Cell Carcinoma; Gastrointestinal Stromal Tumors; Pancreatic Neuroendocrine Tumors
Threshold Pharmaceuticals
 2011-06 PHASE1
NCT02020226 Unknown status
Solid Tumors
Threshold Pharmaceuticals
 2013-11 Phase 1
NCT01144455 COMPLETED
Pancreatic Adenocarcinoma
ImmunoGenesis
 2010-06 PHASE2
NCT01149915 COMPLETED
Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; High-risk Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; Advanced Myelofibrosis
Threshold Pharmaceuticals
 2010-06 PHASE1
NCT00743379 COMPLETED
Non-Small Cell Lung Cancer; Prostate Cancer; Pancreatic Cancer
Threshold Pharmaceuticals
 2008-08 PHASE1; PHASE2
NCT00742963 COMPLETED
Soft Tissue Sarcoma
ImmunoGenesis
 2008-08 PHASE1; PHASE2
NCT01833546 Completed
Solid Tumor|Pancreatic Cancer
Merck KGaA Darmstadt Germany|Threshold Pharmaceuticals
 2013-04-18 Phase 1
NCT01485042 COMPLETED
Solid Tumors
Herbert Hurwitz, MD
 2011-12 PHASE1
NCT00495144 COMPLETED
Tumors; Hypoxia
Threshold Pharmaceuticals
 2007-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-28)

Check the Evofosfamide (TH-302) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Evofosfamide (TH-302) is a hypoxia-activated prodrug that undergoes selective enzymatic reduction within hypoxic cellular microenvironments to release a cytotoxic DNA alkylating mustard, thereby inducing DNA cross-linking, cell-cycle arrest, and apoptosis in hypoxic neoplastic cells. This targeted activation mechanism provides clinical relevance by selectively destroying hypoxic cells within hypoperfused tumor regions, thereby inhibiting tumor progression in clinical trial indications such as pancreatic adenocarcinoma, soft tissue sarcoma, and multiple myeloma.

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.