Clinical Trials

Inavolisib (GDC-0077) is being evaluated across numerous clinical trials spanning Phase 1 through Phase 3 to determine its safety, efficacy, and pharmacokinetic profiles in oncological settings. These trials target diverse indications, including breast, ovarian, colorectal, and metastatic castration-resistant prostate cancers, advanced solid malignancies, hepatic impairment, and genomically altered solid tumors via platform studies like MyTACTIC and TAPISTRY. Sponsored by major pharmaceutical entities, such as Genentech and Hoffmann-La Roche, alongside independent research groups, these investigations range from upcoming and active recruitment to completed status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05862285 RECRUITING
Cancer
Hoffmann-La Roche
 2023-06-01 PHASE3
NCT04589845 ACTIVE_NOT_RECRUITING
Solid Tumors
Hoffmann-La Roche
 2021-01-18 PHASE2
NCT06790693 RECRUITING
Breast Cancer
Hoffmann-La Roche
 2025-04-09 PHASE3
NCT03424005 RECRUITING
Metastatic Breast Cancer
Hoffmann-La Roche
 2018-03-30 PHASE1; PHASE2
NCT04929223 RECRUITING
Metastatic Colorectal Cancer
Hoffmann-La Roche
 2021-10-22 PHASE1
NCT07522697 NOT_YET_RECRUITING
Endometrial Cancer
National Cancer Institute, Naples
 2026-05 PHASE2
NCT05332561 RECRUITING
Early-stage Breast Cancer
German Cancer Research Center
 2023-06-29 PHASE2
NCT07748208 NOT_YET_RECRUITING
Breast Cancer; Diabetes Type II
Hoffmann-La Roche
 2026-09-01 PHASE2
NCT04802759 RECRUITING
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
Hoffmann-La Roche
 2021-06-22 PHASE1; PHASE2
NCT07323576 WITHDRAWN
Colorectal Cancer
Hoffmann-La Roche
 2026-02-01 PHASE2
NCT07405801 RECRUITING
Breast Cancer
Hoffmann-La Roche
 2026-04-07 PHASE2
NCT07618390 NOT_YET_RECRUITING
Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2026-06 PHASE2
NCT07368998 RECRUITING
Breast Cancer
Hoffmann-La Roche
 2026-02-18 PHASE2
NCT05708235 RECRUITING
Breast Cancer
MedSIR
 2024-04-01 PHASE2
NCT07694973 NOT_YET_RECRUITING
Pancreatic Ductal Adenocarcinoma (PDAC)
Fudan University
 2026-08-29 PHASE2
NCT07287150 RECRUITING
Metastatic Castration-Resistant Prostate Cancer
Hoffmann-La Roche
 2026-03-11 PHASE2
NCT07441512 NOT_YET_RECRUITING
TNBC - Triple-Negative Breast Cancer; TNBC
Hu Hai
 2026-03-15 PHASE2
NCT04931342 ACTIVE_NOT_RECRUITING
Ovarian Cancer
Hoffmann-La Roche
 2021-10-07 PHASE2
NCT04449874 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; Colorectal Cancer; Advanced Solid Tumors
Genentech, Inc.
 2020-07-29 PHASE1
NCT07054190 RECRUITING
Breast Cancer
Hoffmann-La Roche
 2025-09-09 PHASE2
NCT06496568 ACTIVE_NOT_RECRUITING
PIK3CA-Mutated Cancers
Hoffmann-La Roche
 2023-12-11 PHASE1
NCT05894239 RECRUITING
Metastatic Breast Cancer
Hoffmann-La Roche
 2023-09-08 PHASE3
NCT03006172 ACTIVE_NOT_RECRUITING
Breast Cancer; Solid Tumor
Genentech, Inc.
 2016-12-13 PHASE1
NCT07245797 NOT_YET_RECRUITING
Breast Cancer
Zhimin Shao
 2025-12-15 PHASE2
NCT05646862 RECRUITING
Breast Cancer
Hoffmann-La Roche
 2023-06-07 PHASE3
NCT04486352 RECRUITING
Endometrial Cancer
Alliance Foundation Trials, LLC.
 2021-10-20 PHASE1; PHASE2
NCT05306041 RECRUITING
HER2-positive Breast Cancer
GBG Forschungs GmbH
 2023-01-02 PHASE2
NCT07144111 RECRUITING
Hepatic Impairment
Genentech, Inc.
 2025-08-21 PHASE1
NCT04551521 COMPLETED
Metastatic or Locally Advanced Malignancies
German Cancer Research Center
 2021-10-13 PHASE2
NCT04849364 TERMINATED
Breast Cancer; Triple Negative Breast Cancer
Bryan Schneider, MD
 2021-08-24 PHASE2
NCT04632992 COMPLETED
Advanced Unresectable or Metastatic Solid Malignancy
Genentech, Inc.
 2021-01-13 PHASE2
NCT04191499 ACTIVE_NOT_RECRUITING
Breast Cancer
Hoffmann-La Roche
 2020-01-29 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the GDC-0077 (Inavolisib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GDC-0077 (Inavolisib) selectively binds to the ATP-binding pocket of phosphatidylinositol 3-kinase alpha (PI3Kα), inhibiting the phosphorylation of PIP2 to PIP3 and downregulating downstream AKT signaling to disrupt cellular proliferation and induce apoptosis in mutant cancer cells. This targeted enzymatic inhibition directly supports its ongoing clinical evaluation for treating PIK3CA-driven neoplasms, including advanced breast cancer, ovarian cancer, and other solid tumors.

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.