CBL0137 Hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 570

Clinical Trials

Multiple clinical trials spanning Early Phase 1 to Phase 1/2 evaluate CBL0137 across diverse oncology indications, including advanced or recurrent solid tumors, hematological malignancies, glioblastoma, pediatric central nervous system neoplasms, cutaneous melanoma, and soft tissue sarcoma. Sponsored by academic institutions, cooperative groups, and industry entities such as Incuron, Children's Oncology Group, Fox Chase Cancer Center, and Roswell Park Cancer Institute, these studies encompass completed, actively recruiting, suspended, and terminated statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05498792	RECRUITING	Locally Advanced or Metastatic Melanoma	Fox Chase Cancer Center	2022-11-30	EARLY_PHASE1
NCT04870944	SUSPENDED	Diffuse Midline Glioma, H3 K27-Altered; Metastatic Malignant Neoplasm in the Central Nervous System; Recurrent Diffuse Intrinsic Pontine Glioma; Recurrent Diffuse Midline Glioma, H3 K27-Altered; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Primary Malignant Central Nervous System Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Primary Malignant Central Nervous System Neoplasm	Children's Oncology Group	2022-01-28	PHASE1; PHASE2
NCT03727789	TERMINATED	Advanced Cutaneous Melanoma of the Extremity; Advanced Sarcoma of the Extremity; Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Recurrent Cutaneous Melanoma of the Extremity; Recurrent Sarcoma of the Extremity; Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8	Roswell Park Cancer Institute	2019-07-01	PHASE1
NCT02931110	TERMINATED	Hematological Malignancies	Incuron	2017-01	PHASE1
NCT01905228	COMPLETED	Solid Tumors; Glioblastoma	Incuron	2013-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-22)

Check the CBL0137 Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CBL0137 binds to and inhibits the histone chaperone FACT complex, triggering chromatin remodeling that simultaneously activates p53 tumor suppressor signaling and represses downstream NF-κB transcription factor activity. This dual modulation induces robust apoptosis and cell cycle arrest in malignant cells, providing the mechanistic rationale for targeting tumor growth across clinically studied conditions such as solid tumors, melanoma, neuro-oncological malignancies, and hematological cancers.

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>).