GO-203 TFA Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 270

Clinical Trials

Multiple Phase 1 and Phase 1/2 clinical trials evaluate the safety, pharmacokinetics, and therapeutic activity of the MUC1 inhibitor GO-203 in relapsed or refractory acute myeloid leukemia, advanced solid tumors, and relapsed or refractory multiple myeloma. Sponsored by institutions including the Dana-Farber Cancer Institute, Beth Israel Deaconess Medical Center, and Genus Oncology, LLC, these studies encompass completed, active but non-recruiting, and withdrawn recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02204085	COMPLETED	Acute Myeloid Leukemia, in Relapse; Recurrent Adult Acute Myeloid Leukemia	Beth Israel Deaconess Medical Center	2014-09	PHASE1; PHASE2
NCT02658396	WITHDRAWN	Multiple Myeloma; Multiple Myeloma in Relapse; Refractory Multiple Myeloma	Dana-Farber Cancer Institute		PHASE1
NCT02204085	Active not recruiting	Acute Myeloid Leukemia in Relapse\|Recurrent Adult Acute Myeloid Leukemia	Beth Israel Deaconess Medical Center\|Dana-Farber Cancer Institute	2014-09	Phase 1\|Phase 2
NCT01279603	COMPLETED	Solid Tumors	Genus Oncology, LLC	2011-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-03)

Check the GO-203 TFA product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GO-203 is a cell-penetrating peptide that directly targets the mucin 1 C-terminal subunit (MUC1-C) and prevents its homodimerization, thereby blocking downstream oncogenic signaling pathways and transcription factor activation. Consequently, inhibition of MUC1-C function induces apoptosis and suppresses cancer cell proliferation, demonstrating clinical relevance for treating MUC1-expressing malignancies such as acute myeloid leukemia, multiple myeloma, and 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>).