MRT-2359 Clinical Trials

Size	Price	Qty
5mg	USD 179
25mg	USD 537

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Monte Rosa Therapeutics, Inc. are evaluating MRT-2359 as a single agent and in combination with apalutamide. These industry-sponsored studies encompass various oncology indications, including non-small cell lung cancer, small cell lung cancer, high-grade neuroendocrine cancer, diffuse large B-cell lymphoma, MYC-amplified solid tumors, HR-positive HER2-negative breast cancer, and castration-resistant prostate cancer. Current recruitment statuses across these trials include recruiting and active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07745361	RECRUITING	Castration-Resistant Prostate Cancer (CRPC); Castration-Resistant Prostate Cancer; Prostate Cancer; Prostate Cancer (Adenocarcinoma)	Monte Rosa Therapeutics, Inc	2026-08	PHASE2
NCT05546268	ACTIVE_NOT_RECRUITING	NSCLC; SCLC; High Grade Neuroendocrine Cancer; DLBCL; L-MYC and N-MYC Amplified Solid Tumors; NSCLC With High or Low L-MYC or N-MYC Expression; HR-positive, HER2-negative Breast Cancer; Prostate Cancer	Monte Rosa Therapeutics, Inc	2022-10-12	PHASE1; PHASE2
NCT05546268	Recruiting	NSCLC\|SCLC\|High Grade Neuroendocrine Cancer\|DLBCL\|L-MYC and N-MYC Amplified Solid Tumors\|NSCLC With High or Low L-MYC or N-MYC Expression\|HR-positive HER2-negative Breast Cancer\|Prostate Cancer	Monte Rosa Therapeutics Inc	2022-10-12	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the MRT-2359 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MRT-2359 acts as a targeted molecular glue degrader of the translation termination factor GSPT1, inducing its ubiquitin-proteasome-mediated degradation to disrupt downstream protein translation. This selective loss of GSPT1 impairs cancer cell survival and blocks proliferation, ultimately mediating potent anti-tumor activity against GSPT1-dependent malignancies such as non-small cell lung cancer, small cell lung cancer, and castration-resistant prostate cancer evaluated in clinical trials.

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>).