CEP-40783 (RXDX-106) Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 517

Clinical Trials

A clinical trial sponsored by Hoffmann-La Roche evaluated the small-molecule inhibitor CEP-40783 (RXDX-106) in patients with advanced or metastatic solid tumors. Designed as an early phase 1 study, the trial aimed to assess the drug's safety and immunomodulatory activity. Official records indicate that patient recruitment for this investigation has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03454243	TERMINATED	Advanced or Metastatic Solid Tumors	Hoffmann-La Roche	2018-02-15	EARLY_PHASE1

(data from https://clinicaltrials.gov, updated on 2019-04-25)

Check the CEP-40783 (RXDX-106) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CEP-40783 (RXDX-106) selectively binds to TAM family receptor tyrosine kinases (TYRO3, AXL, MER) and c-Met, thereby blocking downstream oncogenic signaling cascades and suppressing tumor cell proliferation while reversing immune evasion. This targeted inhibition of receptor signaling and immune resistance mechanisms provides the rationale for its clinical evaluation in advanced or metastatic 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>).