A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT07287150
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2026-03-31
2029-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Participants will receive Inavolisib plus enzalutamide
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.
FoundationOne® CDx (F1CDx) Assay
F1CDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that will be used to determine a participant's biomarker status.
Arm 2
Participants will receive either ARPi switch (enzalutamide or abiraterone) or docetaxel
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.
FoundationOne® CDx (F1CDx) Assay
F1CDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that will be used to determine a participant's biomarker status.
Interventions
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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.
FoundationOne® CDx (F1CDx) Assay
F1CDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that will be used to determine a participant's biomarker status.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
MALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Jewish General Hospital
Montreal, Quebec, Canada
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Reference Study ID Number: CO45813 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2025-521327-67-00
Identifier Type: CTIS
Identifier Source: secondary_id
CO45813
Identifier Type: -
Identifier Source: org_study_id
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