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Compound · clinical trials

Inavolisib

Also listed in trial records as GDC-0077, RO7113755
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 20 trials in our USA, UK, China and India registers that name Inavolisib as an intervention. Synced 24 Sep 2026
20Trials tracked
13Recruiting now
3Lead sponsors
4Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards

Inavolisib is named as a drug or biological intervention in 20 clinical trials in our USA, UK, China and India trial registers, 13 of which are recruiting. Lead sponsors include Hoffmann-La Roche (16), Genentech, Inc. (3) and Fudan University (1). Registered phases: Phase 2, Phase 1, Phase 3, Phase 1/2, Phase 2/3 and Observational. Conditions studied include Breast Cancer; Metastatic Breast Cancer; Solid Tumors.

01

Clinical trials of Inavolisib

20 trials
NCT IDStudyPhaseStatusLead sponsorRegister
NCT05646862 A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
Breast Cancer
Phase 3 Recruiting Hoffmann-La Roche UK, USA, China
NCT05862285 A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
Cancer
Phase 3 Recruiting Hoffmann-La Roche UK, China
NCT05894239 A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (ClinicalTrials.gov ↗)
Metastatic Breast Cancer
Phase 3 Recruiting Hoffmann-La Roche UK, USA, India, China
NCT06790693 A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (ClinicalTrials.gov ↗)
Breast Cancer
Phase 3 Recruiting Hoffmann-La Roche UK, USA, China
NCT07054190 A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer (ClinicalTrials.gov ↗)
Breast Cancer
Phase 2 Recruiting Hoffmann-La Roche USA
NCT07287150 A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer (ClinicalTrials.gov ↗)
Metastatic Castration-Resistant Prostate Cancer
Phase 2 Recruiting Hoffmann-La Roche UK, USA
NCT07368998 To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer (ClinicalTrials.gov ↗)
Breast Cancer
Phase 2 Recruiting Hoffmann-La Roche UK, USA
NCT07405801 A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer (ClinicalTrials.gov ↗)
Breast Cancer
Phase 2 Recruiting Hoffmann-La Roche UK, USA
NCT03424005 A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (ClinicalTrials.gov ↗)
Metastatic Breast Cancer
Phase 1/2 Recruiting Hoffmann-La Roche UK, USA
NCT04802759 A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (ClinicalTrials.gov ↗)
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
Phase 1/2 Recruiting Hoffmann-La Roche USA
NCT04929223 A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) (ClinicalTrials.gov ↗)
Metastatic Colorectal Cancer
Phase 1 Recruiting Hoffmann-La Roche UK, USA
NCT07144111 A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib (ClinicalTrials.gov ↗)
Hepatic Impairment
Phase 1 Recruiting Genentech, Inc. USA
NCT07347600 A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (ClinicalTrials.gov ↗)
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Observational Recruiting Hoffmann-La Roche China
NCT07694973 A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients (ClinicalTrials.gov ↗)
Pancreatic Ductal Adenocarcinoma (PDAC)
Phase 2 Not yet open Fudan University China
NCT04191499 A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (ClinicalTrials.gov ↗)
Breast Cancer
Phase 2/3 Active, closed Hoffmann-La Roche UK, USA, China
NCT04589845 Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Solid Tumors
Phase 2 Active, closed Hoffmann-La Roche UK, USA, China
NCT04931342 A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (ClinicalTrials.gov ↗)
Ovarian Cancer
Phase 2 Active, closed Hoffmann-La Roche UK, USA
NCT03006172 To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
Breast Cancer, Solid Tumor
Phase 1 Active, closed Genentech, Inc. UK, USA
NCT04449874 A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation (ClinicalTrials.gov ↗)
Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors
Phase 1 Active, closed Genentech, Inc. UK, USA
NCT06496568 A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers
PIK3CA-Mutated Cancers
Phase 1 Active, closed Hoffmann-La Roche USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied

16 conditions
Condition (as registered)Trials
Breast Cancer7
Metastatic Breast Cancer3
Solid Tumors1
Cancer1
Solid Tumor1
Metastatic Castration-Resistant Prostate Cancer1
Metastatic Colorectal Cancer1
Non-Small Cell Lung Cancer1
Colorectal Cancer1
Advanced Solid Tumors1
Ovarian Cancer1
PIK3CA-Mutated Cancers1
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1
Hepatic Impairment1
Locally Advanced Breast Cancer1
Pancreatic Ductal Adenocarcinoma (PDAC)1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Hoffmann-La Roche16
Genentech, Inc.3
Fudan University1
04

Trials by country register

A trial with sites in more than one country appears in each of those registers.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Inavolisib works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Inavolisib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 24 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.