CB-5083 Clinical Trials

Size	Price	Qty
5mg	USD 177
25mg	USD 547

Clinical Trials

Several Phase 1 clinical trials sponsored by Cleave Biosciences Inc. have evaluated the safety, pharmacokinetics, and pharmacodynamics of CB-5083. These open-label, dose-escalation, and expansion studies targeted advanced solid tumors and lymphoid hematological malignancies, including relapsed and refractory multiple myeloma. Currently, all recorded clinical trials evaluating the compound have been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02243917	TERMINATED	Advanced Solid Tumors	Cleave Biosciences, Inc.	2014-10-11	PHASE1
NCT02223598	TERMINATED	Lymphoid Hematological Malignancies; Relapsed and Refractory Multiple Myeloma	Cleave Biosciences, Inc.	2014-08-25	PHASE1
NCT02243917	Terminated	Advanced Solid Tumors	Cleave Biosciences Inc.	2014-10-11	Phase 1
NCT02223598	Terminated	Lymphoid Hematological Malignancies\|Relapsed and Refractory Multiple Myeloma	Cleave Biosciences Inc.	2014-08-25	Phase 1

(data from https://clinicaltrials.gov, updated on 2018-02-27)

Check the CB-5083 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CB-5083 is a potent and selective inhibitor of the p97 AAA ATPase that disrupts endoplasmic reticulum-associated degradation and protein homeostasis. This targeted inhibition causes an accumulation of misfolded polyubiquitinated proteins and severe proteotoxic stress, promoting apoptotic cell death in therapeutic contexts such as advanced solid tumors and relapsed or refractory multiple myeloma.

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>).