Clinical Trials

A Phase 1 clinical trial sponsored by Kymera Therapeutics, Inc. evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the selective STAT3 degrader KT-333. The study focused on patients with advanced malignancies, including solid tumors, Non-Hodgkin Lymphoma, Peripheral T-cell Lymphoma, Cutaneous T-Cell Lymphoma, Large Granular Lymphocytic Leukemia, and T-cell Prolymphocytic Leukemia. Having completed recruitment, the investigation established key clinical profile metrics for the molecule across these targeted hematologic and oncologic indications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05225584 COMPLETED
Non Hodgkin Lymphoma (NHL); Peripheral T-cell Lymphoma (PTCL); Cutaneous T-Cell Lymphoma (CTCL); Large Granular Lymphocytic Leukemia (LGL-L); T-cell Prolymphocytic Leukemia (T-PLL); Solid Tumors
Kymera Therapeutics, Inc.
 2022-05-19 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-03-19)

Check the KT-333 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

KT-333 acts as a selective heterobifunctional degrader that recruits the VHL E3 ligase to induce ubiquitin-proteasome-mediated degradation of STAT3, thereby blocking downstream oncogenic signaling pathways and gene transcription. This target depletion suppresses cancer cell proliferation and survival, underlying its clinical evaluation in patients with solid tumors and hematologic malignancies such as Non-Hodgkin lymphoma and T-cell 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.