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Phase 2/3 AAA817 for PSMA-positive mCRPC

This study is testing a new treatment called AAA817 for men with metastatic castration-resistant prostate cancer (mCRPC), which is prostate cancer that has spread and is no longer responding to hormone therapy. You might be able to join if your cancer has a specific marker called PSMA, detected by a PSMA PET/CT scan, and has progressed after previous treatments including [177Lu]Lu-PSMA targeted therapy. The study compares AAA817 to standard treatments chosen by your doctor. Researchers will be looking at how well AAA817 shrinks the cancer (biochemical response rate) and if it causes any side effects. This study aims to enroll 443 participants.

Study design
This is an open-label, multi-center Phase 2/3 study. It compares AAA817 to standard of care treatments, and participants will be randomly assigned to receive one of these.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored for side effects for at least 30 days after your last standard of care dose, or 55 days after your last AAA817 dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06780670

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~443 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:Investigators choice of SoCAAA817

At a glance

Recruiting sites
81 of 81 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biochemical response rate (Phase II)
Measured over from date of randomization up to approximately 24 months
+4 more outcomes measured

Conditions

Prostate Cancer

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Prostate Carcinoma

Where it's being run

81 sites across 42 states
Japan7
China6
Israel6
California5
South Korea4
Taiwan4
Singapore3
Switzerland3

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

adults ≥ 18 years of age.
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

Any investigational agents within 28 days prior to the day of randomization.
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).

What this trial measures

  • Biochemical response rate (Phase II)from date of randomization up to approximately 24 months

    Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement

  • Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase IIfrom day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later

    Safety defined as the type, incidence and severity of AEs and SAEs, and deaths

  • Tolerability of the proposed dose of AAA817- Phase IIFrom on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817

    Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure

  • Radiographic progression-free survival (rPFS)- Phase IIIfrom date of randomization up to approximately 24 months

    Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis

  • Overall survival (OS)- Phase IIIfrom date of randomization up to approximately 24 months

    Percentage of participants who are alive or who are lost to follow-up at the time of analysis