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Clinical Trials in the UK / NCT07287150
Recruiting Phase 2

A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT07287150 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2026-03-11
Last updated
2026-09-03

Condition(s) studied

Metastatic Castration-Resistant Prostate Cancer

Investigational drug(s) / intervention(s)

InavolisibEnzalutamideAbirateroneDocetaxel

Inavolisib: Inavolisib will be administered orally as per the schedule specified in the protocol.

Enzalutamide: Enzalutamide will be administered orally as per the schedule specified in the protocol.

Abiraterone: Abiraterone will be administered orally as per the schedule specified in the protocol.

Docetaxel: Docetaxel will be administered intravenously as per the schedule specified in the protocol.

Study summary

This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features * Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA \>=1 ng/mL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Bone disease progression, defined by PCWG3 criteria, with two or more new metastatic bone lesions on a whole-body radionuclide bone scan * Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for hormone- sensitive prostate cancer (HSPC) or CRPC * Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Fasting glucose \<100 mg/dL and HbA1c \< 5.7% Exclusion Criteria: * Presence of liver metastasis * Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K/AKT/mTOR pathway * Type 1 or Type 2 diabetes mellitus * Prior treatment for mCRPC with cytotoxic chemotherapy or novel hormonal treatments (e.g., androgen receptor degraders, CYP11 inhibitors), with the following treatments permitted: Prior docetaxel in mHSPC, providing no evidence of disease progression occurred during treatment or within 6 months of treatment completion; Prior docetaxel in the adjuvant or neoadjuvant setting providing no evidence of disease progression occurred during treatment or within 12 months of treatment completion; Prior treatment with sipuleucel-T, with the last dose administered \>28 days prior to start of treatment; Prior PARPi therapy, as per local prescribing information, with the last dose administered \>14 days prior to start of treatment; One prior RLT or radiotherapeutic agent (e.g., PSMA-targeted RLT, Radium 223) with the last dose administered \>8 weeks prior to start of treatment * Other concurrent anti-cancer therapy except for androgen deprivation therapy * Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment * Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDS Los Angeles California Recruiting
UCSF San Francisco California Recruiting
Holden Comprehensive Cancer Center Iowa City Iowa Recruiting
Montefiore Einstein Cancer Center The Bronx New York Recruiting
Lifespan Cancer Institute Providence Rhode Island Recruiting
Carolina Urologic Research Center Myrtle Beach South Carolina Recruiting
Royal North Shore Hospital-Pacific Hwy St Leonards New South Wales Recruiting
Sunshine Coast University Hospital Birtinya Queensland Recruiting
Royal Brisbane & Womens Hospital Herston Queensland Recruiting
Box Hill Hospital Box Hill Victoria Recruiting
Irmandade Da Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia Santo André São Paulo Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS São José do Rio Preto São Paulo Recruiting
Instituto Nacional de Cancer - INCa Rio de Janeiro Brazil Recruiting
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP São Paulo Brazil Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Centre de recherche du Centre Hospitalier de l'Universite de Montreal Montreal Quebec Recruiting
Jewish General Hospital Montreal Quebec Recruiting
EDOG - Institut Bergonie - PPDS Bordeaux Gironde Recruiting
Gustave Roussy Villejuif Val-de-Marne Recruiting
Centre Léon Bérard Lyon France Recruiting
Institut Paoli Calmettes Marseille France Recruiting
Universitätsklinikum Freiburg Freiburg im Breisgau Baden-Wurttemberg Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Recruiting
Universitätsklinikum Münster Münster Germany Recruiting
Studienpraxis Urologie Nürtingen Germany Recruiting
Istituti Fisioterapici Ospitalieri Rome Lazio Recruiting
Ospedale San Raffaele S.r.l. - PPDS Milan Lombardy Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Lombardy Recruiting
Hospital MAC León León Guanajuato Recruiting
Productos y Servicios Oncologicos Acacias SA de CV Benito Juárez Mexico CITY (federal District) Recruiting
Health Pharma Professional Research S.A de C.V. Mexico City Mexico CITY (federal District) Recruiting
Seoul National University Bundang Hospital Seongnam-si Gyeonggido Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital, Yonsei University Health System Seoul South Korea Recruiting
Asan Medical Center. Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Hospital Universitario Cruces Barakaldo Vizcaya Recruiting
C.H. Regional Reina Sofia - PPDS Córdoba Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting

+ 8 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07287150 on ClinicalTrials.gov ↗ ← All trials in the UK