Clinical Trials

A clinical trial is currently investigating the therapeutic potential of VVD-130037 (BAY-3605349) in patients with advanced solid tumors. Sponsored by industry sponsor Vividion Therapeutics, Inc., this open-label, multicenter Phase 1 study is actively recruiting participants to evaluate the compound's safety profile, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor efficacy. This first-in-human investigation represents a critical step in establishing the safety and early therapeutic activity of this candidate in oncology.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05954312 RECRUITING
Advanced Solid Tumors
Vividion Therapeutics, Inc.
 2023-07-28 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-08)

Check the VVD-130037(BAY-3605349) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VVD-130037 covalently binds to and activates Kelch-like ECH-associated protein 1 (KEAP1), thereby promoting the ubiquitin-mediated proteasomal degradation of nuclear factor-erythroid 2 p45-related factor 2 (NRF2) and suppressing oncogenic transcriptional activation. This depletion of NRF2 disrupts cellular antioxidant defenses and inhibits tumor cell proliferation, driving robust antitumor activity relevant to the treatment of advanced solid tumors.

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.