NX-1607 (Cbl-b-IN-3) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A Phase 1 clinical trial sponsored by Nurix Therapeutics, Inc. is currently recruiting adult patients to evaluate the safety, tolerability, and preliminary activity of NX-1607. This active study investigates the compound across advanced solid tumors and hematologic malignancies, including non-small cell lung cancer, triple-negative breast cancer, epithelial ovarian cancer, gastric cancer, and diffuse large B-cell lymphoma. Additional indications under evaluation include metastatic melanoma, head and neck squamous cell carcinoma, malignant pleural mesothelioma, and metastatic castration-resistant prostate cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05107674	RECRUITING	Ovarian Cancer, Epithelial; Gastric Cancer; GastroEsophageal Junction (GEJ) Cancer; Head and Neck Squamous Cell Carcinoma; Metastatic or Unresectable Melanoma; Non-small Cell Lung Cancer (NSCLC); Metastatic Castration-resistant Prostate Cancer (mCRPC); Malignant Pleural Mesothelioma (MPM); Triple Negative Breast Cancer (TNBC); Metastatic Urothelial Carcinoma; Cervical Cancer; Diffuse Large B Cell Lymphoma (DLBCL); Richter Transformation; Microsatellite Stable Colorectal Carcinoma	Nurix Therapeutics, Inc.	2021-09-29	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-09-09)

Check the NX-1607 (Cbl-b-IN-3) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NX-1607 target-binds and inhibits Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ubiquitin ligase, thereby blocking ubiquitin-dependent suppressive signaling and restoring immune cell activation upon T-cell receptor stimulation. By enhancing cytokine production and reversing T-cell exhaustion, this immunostimulatory activity counteracts suppressive signals in the tumor microenvironment to inhibit tumor progression in clinical conditions such as non-small cell lung cancer and triple-negative breast 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>).