marked.bio

AKT inhibitor · small molecule

capivasertib

10 active trials across 5 of our biomarkers, targeting AKT. 2 active approvals for a biomarker on marked.bio.

Also known as AZD5363, Truqap.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
capivasertib with fulvestrant
EU (EMA), 2024
locally advanced or metastatic, one or more PIK3CA/AKT1/PTEN alterations, after an endocrine-based regimen EU marketing authorisation 17/06/2024. Source
TruqapBroader labelfulvestrant page 		PIK3CA activating mutation breast (ER+/HER2-) Not approved Approved 2024

CAPItello-291 vs placebo + fulvestrant, 289 with an alteration
PFS 7.3 months vs 3.1 months, HR 0.50 (0.38-0.65)

Trial details and side effects
Patients
HR+/HER2- advanced breast cancer with PIK3CA/AKT1/PTEN alteration (NCT04305496)
Most common side effects
diarrhoea, skin reactions, high blood glucose, low lymphocytes, low haemoglobin, nausea, fatigue, raised triglycerides, vomiting, stomatitis
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)
capivasertib with fulvestrant
FDA, 2023
locally advanced or metastatic, one or more PIK3CA/AKT1/PTEN alterations, after endocrine therapy FDA approval 16/11/2023; companion test FoundationOne CDx. The label covers PIK3CA, AKT1 or PTEN alterations. Source
TruqapBroader labelfulvestrant page 		PIK3CA activating mutation breast (HR+/HER2-) Approved 2023 Not approved

CAPItello-291 vs placebo + fulvestrant, 289 with an alteration
PFS 7.3 months vs 3.1 months, HR 0.50 (0.38-0.65)

Trial details and side effects
Patients
HR+/HER2- advanced breast cancer with PIK3CA/AKT1/PTEN alteration (NCT04305496)
Most common side effects
diarrhoea, skin reactions, high blood glucose, low lymphocytes, low haemoglobin, nausea, fatigue, raised triglycerides, vomiting, stomatitis
Notes
FDA approval summary (2023); figures are for patients with an alteration.
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
PIK3CA activating mutation 7 9 Phase 3
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 2 2 Phase 1/2
EGFR exon 19 deletion / L858R 1 1 Phase 1/2
MSI-H / dMMR 1 1 Phase 2
BRCA1/2 mutation 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of capivasertib.

  1. AstraZeneca 3
  2. Relay Therapeutics 1
  3. Aminex Therapeutics 1
  4. Stemline Therapeutics 1

Trials

10 of 13 trials shown

  1. Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

    Recruiting Phase 3 Relay Therapeutics Started 2025Primary completion 2028-04 NCT06982521

    Zovegalisibcapivasertib FDA EUfulvestrant FDA EU

    One or more known primary oncogenic PIK3CA mutation(s)

    PIK3CA activating mutationPIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer

  2. Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients

    Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2026-10 NCT06635447

    capivasertib FDA EUfulvestrant FDA EU

    Patients with PIK3CA/AKT1/PTEN alterations confirmed by central laboratory NGS testing. (Note: Applicable exclusively to patients en…

    PIK3CA activating mutationBreast Cancer

  3. Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib

    Not yet recruiting Phase 1/2 Shanxi Province Cancer Hospital Started 2026Primary completion 2028-10 NCT07486648

    capivasertibosimertinib FDA EU

    Documented EGFR sensitive mutations (exon19 deletion, L858R mutation) prior to the first-line EGFR-TKI therapy.

    EGFR exon 19 deletion / L858RPIK3CA activating mutationLung Cancer (NSCLC), Lung Cancer (Non-Small Cell), Advanced Non-small-cell Lung Cancer

  4. Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors

    Recruiting Phase 1/2 Aminex Therapeutics Started 2026Primary completion 2028-02 NCT07287917

    AMXT 1501 DicaprateDFMOfulvestrant FDA EUcapivasertib FDA EUpembrolizumab

    …cancer patients: locally advanced or metastatic breast cancer with one or more actionable PIK3CA/AKT1/PTEN-alterations following progression on at least 2 endocrine-based regimens in the metastatic setting or…

    PIK3CA activating mutationMelanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer

  5. Rash & Diarrhea Prophylaxis With Capivasertib

    Recruiting Phase 2 Maryam Lustberg Started 2026Primary completion 2027-04 NCT07426822

    capivasertib FDA EULoperamidefulvestrant FDA EUCeterizine

    Participants with metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as confirmed by local or central testing of tumor tissue and/or circulating tumor DNA (c…

    PIK3CA activating mutationMetastatic HR+/HER2- Breast Cancer

  6. Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

    Active, not recruiting Phase 1/2 Stemline Therapeutics Started 2023Primary completion 2026-12 NCT05563220

    elacestrantalpelisib FDA EUeverolimusribociclibpalbociclib FDA EUcapivasertib FDA EUabemaciclib

    Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation by local laboratory assessment.

    PIK3CA activating mutationBreast Cancer, Metastatic Breast Cancer

  7. A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

    Active, not recruiting Phase 1/2 AstraZeneca Started 2018Primary completion 2024-11 NCT03742102

    durvalumabcapivasertiboleclumabpaclitaxeltrastuzumab deruxtecan FDA EUdatopotamab deruxtecan

    …provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Triple Negative Breast Neoplasms

  8. Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas

    Recruiting Phase 2 Alliance for Clinical Trials in Oncology Started 2015Primary completion 2028-06 NCT02523014

    VismodegibFAK Inhibitor GSK2256098capivasertib FDA EUabemaciclib

    For patients with NF2/CDKN2A/AKT1/PIK3CA/PTEN mutation, CKDN2A copy number loss, or CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1 copy number gain: Age \>= …

    PIK3CA activating mutationIntracranial Meningioma, Recurrent Meningioma, NF2 Gene Mutation

  9. Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015Primary completion 2027-12 NCT02465060

    adavosertibafatinibbinimetinibcapivasertibcopanlisibcrizotinibdabrafenibDasatinibdefactiniberdafitinibfexagratinibipatasertib

    …candidate for Z1M based on local Clinical Laboratory Improvement Act (CLIA) assessment of mismatch repair deficiency (MMRd) by immunohistochemistry (IHC) or microsatellite instability (MSI) status by polyme…

    MSI-H / dMMRAdvanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma

  10. A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

    Active, not recruiting Phase 1 AstraZeneca Started 2020Primary completion 2023-08 NCT04556773

    trastuzumab deruxtecan FDA EUdurvalumabpaclitaxelcapivasertibanastrozolefulvestrantcapecitabine

    Has a history of HER2-low expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) with a validated assay

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Metastatic Breast Cancer