Clinical Trials

A clinical trial sponsored by the biopharmaceutical company Kymera Therapeutics, Inc. evaluated KT-253 in a Phase 1, multicenter, open-label, dose-escalation design. The study assessed the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of the compound in patients with myeloid malignancies, acute lymphocytic leukemia, lymphomas, and advanced solid tumors. Having achieved completed recruitment status, this investigation established key preliminary data regarding the therapeutic application of KT-253 in hematologic and solid malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05775406 COMPLETED
Myeloid Malignancies; Acute Lymphocytic Leukemia; Lymphomas; Advanced Solid Tumors
Kymera Therapeutics, Inc.
 2023-05-15 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-01-27)

Check the KT-253 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a selective heterobifunctional degrader, KT-253 targets murine double minute 2 (MDM2) for proteasomal degradation, thereby preventing MDM2-mediated ubiquitination and suppressing p53 inactivation to drive downstream p53 pathway restoration and cell cycle arrest. This targeted degradation restores p53-dependent apoptotic machinery in p53 wild-type tumor cells, providing therapeutic relevance for clinical conditions including myeloid malignancies, acute lymphocytic leukemia, lymphomas, and 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.