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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
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

NCT06780670

RecruitingPhase 2, Phase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Prostate Cancer

Interventions: Investigators choice of SoC, AAA817, AAA817, AAA817

Countries: United States, Australia, Brazil, China, Hong Kong, Israel, Japan, Malaysia

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 overview

Sex: MALE

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 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).

Other protocol-defined inclusion/exclusion criteria may apply.
Locations (81)
  • Los Angeles, California, United States
  • Palo Alto, California, United States
  • Palo Alto, California, United States
  • Santa Barbara, California, United States
  • Santa Monica, California, United States
  • Hartford, Connecticut, United States
  • Orlando, Florida, United States
  • Athens, Georgia, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Kansas City, Kansas, United States
  • Metairie, Louisiana, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • St Louis, Missouri, United States
  • Omaha, Nebraska, United States
  • Voorhees Township, New Jersey, United States
  • Syracuse, New York, United States
  • The Bronx, New York, United States
  • Gahanna, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Myrtle Beach, South Carolina, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Murray, Utah, United States
  • Seattle, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Darlinghurst, New South Wales, Australia
  • Herston, Queensland, Australia
  • Melbourne, Victoria, Australia
  • + 51 more on CT.gov