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 · NCT06780670 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
AAA817Investigators choice of SoC
What this trial is about
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
Who can take part
Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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).
- ther protocol-defined inclusion/exclusion criteria may apply.
Where it is running
60 locations listed across 19 US states.
- VA Greater LA Healthcare System - Los Angeles, California, United States
- VA Palo Alto Health Care System - Palo Alto, California, United States
- Stanford University Medical Center - Palo Alto, California, United States
- Sansum Clinic - Santa Barbara, California, United States
- Saint Johns Cancer Institute - Santa Monica, California, United States
- Hartford Hospital - Hartford, Connecticut, United States
- AdventHealth - Orlando, Florida, United States
- University Cancer and Blood Center LLC - Athens, Georgia, United States
- Emory University - Atlanta, Georgia, United States
- Indiana University - Indianapolis, Indiana, United States
- University of Kansas Hospital - Kansas City, Kansas, United States
- East Jefferson Hospital - Metairie, Louisiana, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- WA Uni School Of Med - St Louis, Missouri, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- New Jersey Urology LLC - Voorhees Township, New Jersey, United States
- Associated Med Professionals of NY - Syracuse, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- Central Ohio Urology Group - Gahanna, Ohio, United States
- Fox Chase Cancer Center - Philadelphia, Pennsylvania, United States
- Carolina Urologic Research Center - Myrtle Beach, South Carolina, United States
- Texas Oncology - Dallas, Texas, United States
- Urology San Antonio - San Antonio, Texas, United States
- Utah Intermountain Medical Center - Murray, Utah, United States
- Fred Hutchinson Cancer Research Center - Seattle, Washington, United States
- Medical College Of Wisconsin - Milwaukee, Wisconsin, United States
- Novartis Investigative Site - Basel, Switzerland
- Novartis Investigative Site - Beersheba, Israel
- Novartis Investigative Site - Beijing, China
- Novartis Investigative Site - Beijing, China
- Novartis Investigative Site - Bellinzona, Switzerland
- Novartis Investigative Site - Bern, Switzerland
- Novartis Investigative Site - Chiba, Japan
- Novartis Investigative Site - Fukuoka, Japan
- Novartis Investigative Site - Fukuoka, Japan
- Novartis Investigative Site - Fukuoka, Japan
- Novartis Investigative Site - Fukushima, Japan
- Novartis Investigative Site - Guangzhou, China
- Novartis Investigative Site - Haifa, Israel
- Novartis Investigative Site - Hong Kong, Hong Kong
- Novartis Investigative Site - Ishikawa, Japan
- Novartis Investigative Site - Jerusalem, Israel
- Novartis Investigative Site - Kyoto, Japan
- Novartis Investigative Site - Petah Tikva, Israel
- Novartis Investigative Site - Ramat Gan, Israel
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Shanghai, China
- Novartis Investigative Site - Shanghai, China
- Novartis Investigative Site - Singapore, Singapore
- Novartis Investigative Site - Singapore, Singapore
- Novartis Investigative Site - Singapore, Singapore
- Novartis Investigative Site - Taipei, Taiwan
- Novartis Investigative Site - Taipei, Taiwan
- Novartis Investigative Site - Taipei, Taiwan
- Novartis Investigative Site - Taoyuan, Taiwan
- Novartis Investigative Site - Tel Aviv, Israel
Showing 60 of 81 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →