Xevinapant (AT406) Clinical Trials

Size	Price	Qty
5mg	USD 167
25mg	USD 497

Clinical Trials

Multiple clinical trials across early to late phases evaluate Xevinapant (AT406) across diverse indications, including head and neck squamous cell carcinoma, acute myelogenous leukemia, solid tumors, and healthy volunteer pharmacokinetics. These studies are sponsored by commercial developers such as Debiopharm International SA and EMD Serono, alongside cooperative networks and academic centers including ECOG-ACRIN and Memorial Sloan Kettering Cancer Center. While several early-phase safety and pharmacokinetic studies achieved completion, multiple advanced-phase efficacy evaluations were ultimately terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06084845	WITHDRAWN	Head and Neck Squamous Cell Carcinoma; Hypopharyngeal Squamous Cell Carcinoma; Laryngeal Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma; Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage III Hypopharyngeal Carcinoma AJCC v8; Stage III Laryngeal Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Hypopharyngeal Carcinoma AJCC v8; Stage IV Laryngeal Cancer AJCC v8; Stage IV Lip and Oral Cavity Cancer AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8	ECOG-ACRIN Cancer Research Group	2024-04-12	PHASE2
NCT06463184	WITHDRAWN	Recurrent High-grade Glioma	H. Lee Moffitt Cancer Center and Research Institute	2024-07-22	PHASE1
NCT06145412	COMPLETED	Head and Neck Cancer	Memorial Sloan Kettering Cancer Center	2023-11-16	PHASE2
NCT06110195	TERMINATED	Head and Neck Cancer; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck	University of Chicago	2024-01-24	PHASE1
NCT05724602	TERMINATED	Locally Advanced Head and Neck Squamous Cell Carcinoma	European Organisation for Research and Treatment of Cancer - EORTC	2023-11-15	PHASE2
NCT05930938	TERMINATED	Squamous Cell Carcinoma of the Head and Neck	Groupe Oncologie Radiotherapie Tete et Cou	2023-12-12	PHASE3
NCT04459715	TERMINATED	Squamous Cell Carcinoma of the Head and Neck	EMD Serono Research & Development Institute, Inc.	2020-08-07	PHASE3
NCT05386550	TERMINATED	Head and Neck Cancer	EMD Serono Research & Development Institute, Inc.	2022-10-06	PHASE3
NCT06056310	TERMINATED	Head and Neck Cancer	EMD Serono Research & Development Institute, Inc.	2024-01-18	PHASE1
NCT05519540	COMPLETED	Healthy	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	2022-09-26	PHASE1
NCT04962724	COMPLETED	Healthy Volunteers	Debiopharm International SA	2021-08-02	PHASE1
NCT01078649	COMPLETED	Cancer; Solid Tumors; Lymphoma; Malignancy	Debiopharm International SA	2010-03-29	PHASE1
NCT01265199	TERMINATED	Acute Myelogenous Leukemia (AML)	Ascenta Therapeutics	2011-02	PHASE1
NCT01265199	Terminated	Acute Myelogenous Leukemia (AML)	Ascenta Therapeutics\|The Leukemia and Lymphoma Society	2011-02	Phase 1
NCT01078649	Completed	Cancer\|Solid Tumors\|Lymphoma\|Malignancy	Debiopharm International SA	2010-03-29	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-07-25)

Check the Xevinapant (AT406) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Xevinapant (AT406) functions as a potent Smac mimetic that selectively binds the BIR3 domains of XIAP, cIAP1, and cIAP2, thereby blocking IAP-mediated inhibition of apoptosis and triggering rapid enzymatic degradation of cIAP1. This degradation relieves suppression on caspase-9 to reactivate intrinsic apoptotic signaling cascades, promoting programmed tumor cell death and suppressing neoplastic growth in clinical targets such as head and neck squamous cell carcinoma and acute myelogenous leukemia.

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>).