Clinical Trials

Tulmimetostat (CPI-0209) is currently evaluated across several clinical trials as monotherapy or combination regimens for advanced solid tumors and hematologic malignancies, including mycosis fungoides, Sézary syndrome, platinum-sensitive recurrent ovarian cancer, non-small cell lung cancer, and metastatic prostate cancer. These Phase I and Phase I/II studies, sponsored by academic institutions, government entities such as the National Cancer Institute, and industry partners including MorphoSys AG and Novartis Pharmaceuticals, consist predominantly of actively recruiting protocols alongside active, non-recruiting trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07190300 RECRUITING
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Novartis Pharmaceuticals
 2026-01-13 PHASE1; PHASE2
NCT04104776 RECRUITING
Advanced Solid Tumor; Diffuse Large B Cell Lymphoma; Lymphoma, T-Cell; Mesothelioma, Malignant; Prostatic Neoplasms, Castration-Resistant; Endometrial Cancer; Ovarian Clear Cell Carcinoma; Metastatic Castration-resistant Prostate Cancer
Novartis Pharmaceuticals
 2019-09-18 PHASE1; PHASE2
NCT07206056 RECRUITING
Progressive Metastatic Castrate Resistant Prostate Cancer
Novartis Pharmaceuticals
 2025-10-15 PHASE1; PHASE2
NCT05467748 RECRUITING
Non Small Cell Lung Cancer
VA Office of Research and Development
 2025-12-08 PHASE1; PHASE2
NCT05944562 ACTIVE_NOT_RECRUITING
Mycosis Fungoides; Sezary Syndrome; Mycosis Fungoides/Sezary Syndrome
Washington University School of Medicine
 2024-01-09 PHASE1
NCT05944562 Recruiting
Mycosis Fungoides|Sezary Syndrome|Mycosis Fungoides/Sezary Syndrome
Washington University School of Medicine|MorphoSys AG|The Foundation for Barnes-Jewish Hospital|Swim Across America|Daniel E. Corbin Jr. Lymphoma Fund
 2024-01-09 Phase 1
NCT05942300 Recruiting
Recurrent Ovarian Cancer
Lan Coffman|MorphoSys AG|National Cancer Institute (NCI)|University of Pittsburgh
 2024-01-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-23)

Check the Tulmimetostat (CPI-0209) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tulmimetostat selectively binds to and inhibits enhancer of zeste homolog 2 (EZH2), thereby preventing trimethylation of lysine 27 on histone H3 (H3K27me3) and repressing chromatin-mediated transcriptional silencing of tumor suppressor genes. This epigenetic reactivation restores normal cell differentiation and induces apoptotic pathways, suppressing tumor cell proliferation in clinical indications such as prostate cancer, ovarian cancer, non-small cell lung cancer, and T-cell lymphomas.

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.