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Alinamin

(Ipatasertib)

Phase 3Small molecule

Ipatasertib is an experimental cancer drug being tested to treat breast cancer and other solid tumors, often used in combination with other cancer medications to help stop cancer cells from growing and surviving.[1] Alinamin is currently being investigated across 15 indications[3], with its most advanced program in Phase 3.[1]

Alinamin is one of 331 small molecule programs targeting Advanced Lymphoma. It is currently in Phase 3.

15

Indications

52

Total Trials

22

Active Trials

330

Competitors

Pipeline

Status by Indication[3][1]

Indication

Advanced LymphomaActive, not recruiting

FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaActive, not recruiting

Inoperable, Locally Advanced or Metastatic, ER-Positive Breast CancerRecruiting

Metastatic Breast CancerRecruiting

Solid TumorActive, not recruiting

Fallopian Tube Endometrioid AdenocarcinomaActive, not recruiting

TreatmentActive, not recruiting

Squamous Cell Cancer of the Head and NeckActive, not recruiting

Breast CancerActive, not recruiting

Prostate CancerCompleted

Advanced LymphomaPhase 2

Active, not recruiting

FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaPreclinical

Active, not recruiting

Inoperable, Locally Advanced or Metastatic, ER-Positive Breast CancerPreclinical

Recruiting

Metastatic Breast CancerPreclinical

Recruiting

Solid TumorPhase 2

Active, not recruiting

Fallopian Tube Endometrioid AdenocarcinomaPhase 1

Active, not recruiting

TreatmentPhase 2

Active, not recruiting

Squamous Cell Cancer of the Head and NeckPhase 2

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Prostate CancerPhase 3

Completed

Showing 10 of 15 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Alinamin

Blenoxane

Bristol-Myers Squibb

Spravato

Feraheme

AAzurity Pharmaceuticals

Systemic Therapy

Bristol-Myers Squibb

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Tianeptine

Diuretic

RReprieve Cardiovascular, Inc

Recombinant Human Endostatin

PPeking University Third Hospital

Metfomin

UUniversity of Texas Southwestern Medical Center

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Cholangiocarcinoma

NCT04551521

Phase 3Active, not recruiting

Breast Cancer

NCT04650581

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Q1 2027

Phase 2Active, not recruiting

Treatment

NCT06400251

PreclinicalActive, not recruiting

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma

NCT05538897

Phase 2Active, not recruiting

Locally Advanced Malignant Solid Neoplasm

NCT05554380

Clinical

Trials by Indication[1]

Breast Cancer11 trials

A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer

Completed· Roche logo

Roche·Phase 2·NCT02301988·151 enrolled

A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Completed· Roche logo

Roche·Phase 1/2·NCT03280563·144 enrolled

Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor

Active, not recruiting·CCanadian Cancer Trials Group·Phase 3·NCT04650581·250 enrolled

Show 8 more trials

Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients

Completed·SSOLTI Breast Cancer Research Group·Phase 1·NCT04253561·17 enrolled

A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

Completed· Roche logo

Roche·Phase 2·NCT02162719·124 enrolled

Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

Recruiting·GGerman Cancer Research Center·Phase 2·NCT05332561·240 enrolled

Pre-operative Immunotherapy Combination Strategies in Breast Cancer

Completed·QQueen Mary University of London·Phase 2·NCT03395899·71 enrolled

Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Treating Patients With Metastatic Triple Negative Breast Cancer

Completed·—·Phase 1/2·NCT03853707·28 enrolled

A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer

Terminated· Roche logo

Roche·Phase 1·NCT04060862·20 enrolled

Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression

Recruiting·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT04920708·324 enrolled

Clinical Trial to Evaluate Safety and Anti-tumor Activity of AKT Inhibitor, Ipatasertib,With Endocrine Therapy With/Without CDK 4/6 Inhibitor for Patients With Metastatic Hormone Receptor Positive Breast Cancer (TAKTIC)

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT03959891·77 enrolled

Prostate Cancer6 trials

Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy

Completed· Roche logo

Roche·Phase 1/2·NCT01485861·298 enrolled

Prostate Cancer Biomarker Enrichment and Treatment Selection

Active, not recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03385655·200 enrolled

A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.

Completed· Roche logo

Roche·Phase 1·NCT03840200·51 enrolled

Show 3 more trials

Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer

Terminated·DDavid VanderWeele·Phase 1/2·NCT04737109·6 enrolled

A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Terminated· Roche logo

Roche·Phase 1·NCT04404140·6 enrolled

Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer

Completed· Roche logo

Roche·Phase 3·NCT03072238·1,101 enrolled

Triple-Negative Breast Cancer4 trials

A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Completed· Roche logo

Roche·Phase 1·NCT03800836·139 enrolled

A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Completed· Roche logo

Roche·Phase 3·NCT04177108·242 enrolled

Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer

Completed·MMedSIR·Phase 2·NCT04464174·54 enrolled

Show 1 more trial

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

Completed· Roche logo

Roche·Phase 3·NCT03337724·579 enrolled

Locally Advanced or Metastatic Solid Tumors2 trials

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT01562275·67 enrolled

A Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Participants With Locally Advanced Or Metastatic Solid Tumors.

Completed· Roche logo

Roche·Phase 1·NCT04341259·12 enrolled

Ovarian Cancer2 trials

To Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer

Withdrawn·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT04561817

A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04931342·176 enrolled

23 more indications

Advanced Solid Tumors2 trials

A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response

Completed· Roche logo

Roche·Phase 2·NCT04632992·252 enrolled

Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT01362374·122 enrolled

Squamous Cell Cancer of the Head and Neck1 trial

Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05172258·52 enrolled

Cancer of Unknown Primary Site1 trial

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Completed· Roche logo

Roche·Phase 2·NCT03498521·529 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Non-Small Cell Lung Cancer1 trial

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03337698·314 enrolled

Gastroesophageal Junction Cancer1 trial

A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

Completed· Roche logo

Roche·Phase 2·NCT01896531·153 enrolled

Endometrial Cancer1 trial

A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer

Recruiting·AAlliance Foundation Trials, LLC.·Phase 1/2·NCT04486352·148 enrolled

Trial1 trial

A Trial of Ipatasertib in Combination With Atezolizumab

Active, not recruiting·IInstitute of Cancer Research, United Kingdom·Phase 1/2·NCT03673787·87 enrolled

Hepatic Impairment1 trial

A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT03341884·29 enrolled

Metastatic NSCLC1 trial

Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy

Unknown status·JJun Zhang, MD, PhD·Phase 2·NCT04467801·60 enrolled

Neoadjuvant Chemotherapy1 trial

Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC

Active, not recruiting·QQueen Mary University of London·Phase 2·NCT05498896·146 enrolled

Treatment1 trial

Testing Ipatasertib as Potentially Targeted Treatment in Cancers With AKT Genetic Changes (MATCH - Subprotocol Z1K)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06400251·35 enrolled

Advanced Malignant Solid Neoplasm1 trial

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564377·2,900 enrolled

Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v81 trial

Phase 1/1b Study of AKT Inhibitor Ipatasertib With Chemoradiation for Locally Advanced Head and Neck Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05172245·46 enrolled

Metastatic Breast Cancer1 trial

A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)

Recruiting· Roche logo

Roche·Preclinical·NCT03424005·1,132 enrolled

Solid Tumor1 trial

Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04589845·920 enrolled

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)

Recruiting· Roche logo

Roche·Preclinical·NCT04802759·316 enrolled

Fallopian Tube Endometrioid Adenocarcinoma1 trial

Phase I/IB Safety and Pharmacodynamic Study of Neoadjuvant (NACT) Paclitaxel and Carboplatin With Ipatasertib as Initial Therapy of Ovarian Cancer PTMA 100805

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05276973·25 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Locally Advanced Malignant Solid Neoplasm1 trial

Phase 2 Study of Paclitaxel (NSC #673089) + Ipatasertib (NSC #781451) in Taxane-Refractory Participants With PTEN/AKT-Altered Advanced Non-Breast Solid Tumors: A ComboMATCH Treatment Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554380·33 enrolled

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma1 trial

A Phase IB and Randomized Phase II Trial of Megestrol Acetate With or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT05538897·96 enrolled

Cholangiocarcinoma1 trial

FIGHT-302: Pemigatinib vs Chemo in FGFR2+ CCA

Active, not recruiting· Incyte logo

Incyte·Phase 3·NCT04551521·432 enrolled

Unspecified4 trials

A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib

Completed· Roche logo

Roche·Phase 1·NCT03222310·15 enrolled

A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT02063581·16 enrolled

Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects

Completed· Roche logo

Roche·Phase 1·NCT02536391·18 enrolled

Show 1 more trial

An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study

Recruiting· Roche logo

Roche·Phase 3·NCT05862285·100 enrolled

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Ipatasertib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ipatasertib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ipatasertib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serine/threonine-Protein Kinase AKT Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Roche

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