Clinical Trials

Multiple clinical trials in Phase I and Phase I/II are evaluating ON123300 (narazaciclib) as monotherapy or combined with dexamethasone or letrozole to assess its safety, tolerability, pharmacokinetics, and therapeutic potential. Sponsored by Traws Pharma, Inc. and academic investigators at the Icahn School of Medicine at Mount Sinai, these studies target advanced oncological indications including solid tumors, relapsed or refractory multiple myeloma, and endometrioid endometrial cancer. Currently, these trials exhibit varied recruitment statuses ranging from active and planned enrollment to terminated status or unknown updates.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05705505 UNKNOWN
Endometrioid Endometrial Cancer
Traws Pharma, Inc.
 2023-03-29 PHASE1; PHASE2
NCT06351644 TERMINATED
Relapsed and/or Refractory Multiple Myeloma
Adriana Rossi
 2024-10-02 PHASE1; PHASE2
NCT04739293 UNKNOWN
Solid Tumors, Adult
Traws Pharma, Inc.
 2021-05-13 PHASE1
NCT06351644 Not yet recruiting
Relapsed and/or Refractory Multiple Myeloma
Adriana Rossi|Icahn School of Medicine at Mount Sinai
 2024-06-03 Phase 1|Phase 2
NCT04739293 Recruiting
Solid Tumors Adult
Traws Pharma Inc.
 2021-05-13 Phase 1

(data from https://clinicaltrials.gov, updated on 2023-12-12)

Check the ON123300 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ON123300 functions as a potent multi-targeted kinase inhibitor that directly binds CDK4, Ark5, RET, Fyn, FGFR1, and PDGFRβ to block downstream intracellular phosphorylation and proliferative signaling pathways. By suppressing these critical survival and cell-cycle cascades, the compound promotes G1 phase growth arrest and induces tumor cell apoptosis, which counteracts oncogenic progression in solid tumors, multiple myeloma, and endometrioid endometrial cancer.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.