GDC-0152 Clinical Trials

Size	Price	Qty
10mg	USD 270
100mg	USD 970

Clinical Trials

Genentech, Inc. sponsored several clinical trials evaluating the experimental therapeutic agent GDC-0152 in patients with advanced solid cancers. These Phase 1, open-label, dose-escalation investigations were designed to assess the safety, tolerability, and pharmacokinetics of GDC-0152 following intravenous administration. According to official registry entries, recruitment for these trials is officially listed as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00977067	TERMINATED	Solid Cancers	Genentech, Inc.	2007-06	PHASE1
NCT00977067	Terminated	Solid Cancers	Genentech Inc.	2007-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2017-06-21)

Check the GDC-0152 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GDC-0152 potently binds to the BIR3 domains of inhibitor of apoptosis proteins, including XIAP, cIAP1, cIAP2, and ML-IAP, which blocks their downstream inhibition of caspase cascades and anti-apoptotic signaling. By restoring pro-apoptotic biochemical signaling, the compound triggers cell death in malignant cells, providing the biological rationale for its clinical investigation in solid 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>).