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

ID#: NCT06780670

Age: 18 - 100 years

Gender: Male

Healthy Subjects: No

Study Phase: Phase 2/Phase 3

Recruitment Status: Recruiting

Start Date: February 27, 2025

End Date: July 19, 2033

Contact Information:
Novartis Pharmaceuticals
1-888-669-6682
Novartis Pharmaceuticals
+41613241111
Summary: This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy. 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
Eligibility:

Inclusion Criteria: ∙

- 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 Criteria:

- 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 2 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). Other protocol-defined inclusion/exclusion criteria may apply.
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