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
About this study
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
- Condition
- Prostate Cancer
- Tested
- Investigators choice of SoC, AAA817, AAA817, AAA817
- Sponsor
- Novartis Pharmaceuticals
Who can join
- Age
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 12
- Minimum age: 18 years
- Maximum age: 100 years
- Eligible sex: Male
- Study condition: Prostate Cancer
- 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 8
- 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.
Where
93 sites, 93 recruiting
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Beijing, China
and 87 more sites on ClinicalTrials.gov
Contact
-
Novartis Pharmaceuticals
1-888-669-6682 novartis.email@novartis.com
-
Novartis Pharmaceuticals
+41613241111
Potential match only. Final eligibility is determined by the study team.