Clinical Trials

Genentech, Inc. is sponsoring several clinical trials evaluating GDC-1971 as a monotherapy or in combination with targeted or immunotherapeutic agents in patients with advanced or metastatic solid tumors, colorectal cancer, and non-small cell lung cancer. Encompassing actively recruiting, completed, and active but non-recruiting cohorts, these Phase 1 studies assess the safety, pharmacokinetics, tolerability, and preliminary clinical activity of the compound.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04449874 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; Colorectal Cancer; Advanced Solid Tumors
Genentech, Inc.
 2020-07-29 PHASE1
NCT05954871 COMPLETED
Colorectal Cancer; Non-Small Cell Lung Cancer
Genentech, Inc.
 2024-01-08 PHASE1
NCT05487235 COMPLETED
Advanced Solid Tumors; Metastatic Solid Tumors
Genentech, Inc.
 2022-08-17 PHASE1
NCT05954871 Recruiting
Colorectal Cancer|Non-Small Cell Lung Cancer
Genentech Inc.
 2024-01-08 Phase 1
NCT05487235 Recruiting
Advanced Solid Tumors|Metastatic Solid Tumors
Genentech Inc.
 2022-08-17 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the GDC-1971 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GDC-1971 selectively binds to and inhibits Src homology 2 domain-containing phosphatase 2 (SHP2), thereby suppressing downstream RAS-MAPK signaling cascades to arrest tumor cell proliferation and survival. By blocking this oncogenic pathway, the compound attenuates growth in SHP2-dependent malignancies, providing a mechanistic rationale for its clinical investigation in advanced solid tumors, non-small cell lung cancer, and colorectal cancer.

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.