Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
NCT ID: NCT06780670
Last Updated: 2025-11-12
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/PHASE3
432 participants
INTERVENTIONAL
2025-02-27
2033-07-19
Brief Summary
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Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase II: AAA817 Dose B
AAA817 will be given for a number of cycles; a cycle = 8 weeks
AAA817
Investigational treatment is the Dose B of AAA817
Phase III: Investigator's choice of SoC
Participants will be given Standard of Care (SOC) treatment per Investigator's choice.
Investigators choice of SoC
The control treatment in Phase III is investigator's choice of SoC
Phase II: AAA817 Dose A
AAA817 Dose A will be given for a number of cycles: a cycle = 8 weeks
AAA817
The investigational treatment is AAA817
Phase III: Recommended Phase 3 Dose of AAA817
Rp3D of AAA817 will be given for a number of cycles; a cycle = 8 weeks
AAA817
The investigational treatment is AAA817
Interventions
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Investigators choice of SoC
The control treatment in Phase III is investigator's choice of SoC
AAA817
The investigational treatment is AAA817
AAA817
The investigational treatment is AAA817
AAA817
Investigational treatment is the Dose B of AAA817
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status of 0 to 2.
* histopathological and/or cytological confirmation of adenocarcinoma of the prostate.
* PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed,
* castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
* Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after \[177Lu\]Lu-PSMA targeted therapy.
* ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
* eGFR as requested by the sponsor
Exclusion Criteria
* Any 225Ac-based investigational compound used prior to the day of randomization.
* Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
* Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
* Baseline xerostomia ≥ Grade 2 by CTCAE v.5
* History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, non-invasive malignant colon polyps that have been removed).
18 Years
100 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
WA Uni School Of Med
St Louis, Missouri, United States
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Chengdu, Sichuan, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Shanghai, , China
Novartis Investigative Site
Tianjin, , China
Novartis Investigative Site
Petah Tikva, , Israel
Novartis Investigative Site
Ramat Gan, , Israel
Novartis Investigative Site
Tel Aviv, , Israel
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Kyoto, , Japan
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Phone: +41613241111
Facility Contacts
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Jenna Baumeister
Role: primary
Ashley Murray
Role: primary
Other Identifiers
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2024-512342-42-00
Identifier Type: OTHER
Identifier Source: secondary_id
CAAA817A12201
Identifier Type: -
Identifier Source: org_study_id