Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials have evaluated the therapeutic potential of PF-04929113 (SNX-5422) across various oncology indications, including refractory solid tumors, lymphomas, leukemias, and other hematologic neoplasms. Focusing on safety, pharmacokinetics, and novel combination strategies, these investigations encompass completed, terminated, and withdrawn recruitment statuses. The trials were sponsored primarily by Esanex Inc. alongside government institutions such as the National Cancer Institute.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02973399 TERMINATED
Cancer
Esanex Inc.
 2017-02-07 PHASE1
NCT02914327 WITHDRAWN
Cancer
Esanex Inc.
 2017-02-02 PHASE1
NCT02063958 COMPLETED
Cancer
Esanex Inc.
 2014-02 PHASE1
NCT02973399 Terminated
Cancer
Esanex Inc.
 2017-02-07 Phase 1
NCT02914327 Withdrawn
Cancer
Esanex Inc.
 2017-02-02 Phase 1
NCT01892046 COMPLETED
Cancer
Esanex Inc.
 2013-11 PHASE1
NCT02612285 TERMINATED
Cancer
Esanex Inc.
 2016-03 PHASE2
NCT01635712 COMPLETED
Cancer
Esanex Inc.
 2014-02 PHASE1
NCT01851096 COMPLETED
Cancer
Esanex Inc.
 2013-03 PHASE1
NCT01848756 TERMINATED
Cancer
Esanex Inc.
 2013-04 PHASE1; PHASE2
NCT01611623 COMPLETED
Cancer
Esanex Inc.
 2012-05 PHASE1
NCT00647764 COMPLETED
Solid Tumor Malignancy; Lymphoid Malignancy (Lymphoma and CLL); Leukemia; Lymphoma
Esanex Inc.
 2008-03 PHASE1
NCT00595686 COMPLETED
Hematologic Neoplasms
Esanex Inc.
 2008-01 PHASE1
NCT00506805 COMPLETED
Cancer
Esanex Inc.
 2007-06 PHASE1
NCT00644072 COMPLETED
Lymphoma; Neoplasms
National Cancer Institute (NCI)
 2008-03-07 PHASE1
NCT00644072 Completed
Lymphoma|Neoplasms
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
 2008-03-07 Phase 1
NCT00647764 Completed
Solid Tumor Malignancy|Lymphoid Malignancy (Lymphoma and CLL)|Leukemia|Lymphoma
Esanex Inc.|National Cancer Institute (NCI)
 2008-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2019-02-22)

Check the PF-04929113 (SNX-5422) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-04929113 (SNX-5422) is a prodrug that converts to SNX-2112, which selectively binds to heat shock protein 90 and inhibits its molecular chaperone activity, leading to the proteasomal degradation of oncogenic client proteins including HER2 and AKT. By suppressing these downstream signaling pathways, the compound blocks tumor cell proliferation and induces apoptosis, underlying its clinical investigation in refractory solid tumors, lymphomas, and leukemias.

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.