Clinical Trials

A clinical trial sponsored by the City of Hope Medical Center is currently investigating COH-29 in adult patients with refractory solid tumors. This active, non-recruiting, early-phase open-label study evaluates the safety, tolerability, and pharmacokinetics of the compound to establish its maximum tolerated dose. By targeting ribonucleotide reductase, this dose-escalation effort aims to assess the therapeutic potential of the drug in advanced oncological settings resistant to standard regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02112565 ACTIVE_NOT_RECRUITING
Unspecified Adult Solid Tumor, Protocol Specific
City of Hope Medical Center
 2016-06-13 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-08)

Check the COH-29 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

COH-29 selectively inhibits ribonucleotide reductase by binding the RRM1/RRM2 subunit complex, which blocks the conversion of ribonucleotides to deoxyribonucleotides and depletes the cellular dNTP pools required for DNA replication and repair. This inhibition halts DNA synthesis, leading to S-phase cell cycle arrest and apoptosis in rapidly dividing cancer cells, providing the biological foundation for its evaluation in clinical trials for refractory adult 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.