Clinical Trials

A clinical trial sponsored by Genentech Inc. evaluated the therapeutic potential of GDC-0349 in patients presenting with locally advanced or metastatic solid tumors as well as Non-Hodgkin's lymphoma. This completed, open-label Phase 1 study focused on assessing the safety, tolerability, and pharmacokinetic profile of the compound during dose escalation. The early-phase evaluation provides fundamental clinical insights regarding the safety parameters and pharmacological feasibility of targeting mTOR signaling in oncology patients.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01356173 Completed
Non-Hodgkin''s Lymphoma Solid Tumor
Genentech Inc.
 2011-06 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the GDC-0349 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GDC-0349 acts as a potent, ATP-competitive inhibitor of the mammalian target of rapamycin (mTOR) with a Ki of 3.8 nM, effectively blocking downstream mTOR signaling networks essential for protein translation and cellular growth. This targeted enzymatic inhibition leads to cell cycle arrest and suppressed cell survival, providing the mechanistic rationale for evaluating its therapeutic efficacy against solid tumors and Non-Hodgkin's lymphoma.

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>).

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Note: Technical data last updated: Sep 1, 2026.