Clinical Trials

Multiple clinical trials sponsored by Genentech, Inc. evaluated the clinical application of GDC-0575 in patients with solid tumors and lymphoma. These completed, early-phase studies assessed the safety profile, tolerability, and pharmacokinetic properties of GDC-0575 as both a standalone monotherapy and in combination with other therapeutic agents. Together, these entries reflect a targeted effort to determine dosage safety and preliminary clinical feasibility in hematological and solid malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01564251 COMPLETED
Lymphoma, Solid Tumor
Genentech, Inc.
 2012-03-23 PHASE1
NCT01564251 Completed
Lymphoma Solid Tumor
Genentech Inc.
 2012-03-23 Phase 1

(data from https://clinicaltrials.gov, updated on 2020-02-25)

Check the GDC-0575 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GDC-0575 selectively binds to checkpoint kinase 1 (CHK1), inhibiting its catalytic activity and disrupting downstream DNA damage checkpoint signaling required for cell cycle arrest and repair processes. This loss of checkpoint control induces premature mitotic entry with unrepaired DNA lesions and triggers apoptotic cell death, ultimately suppressing tumor cell proliferation in solid tumors and 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>).

Jump to

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