Last updated 7 days ago
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
432 patients around the world
Available in United States, Brazil
Study CAAA817A12201 consists of 2 parts: a randomized, open-label, international,
multicenter, phase II study (Phase II) to collect more information to support the
proposed dose of AAA817 and a randomized, open-label, international, multicenter, 2- arm
phase III study (Phase III) aimed to evaluate the efficacy and safety of proposed dose of
AAA817 vs. investigator's choice of standard of care (SoC) in the treatment of adult
participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)
who had treatments with ARPI and taxane-based chemotherapy, and progressed on or after
[177Lu]Lu-PSMA targeted therapy. The purpose of the phase II part (Phase II) of this
study is to collect additional information to support proposed phase III dose of AAA817.
Novartis Pharmaceuticals
432Patients around the world
This study is for people with
Prostate cancer
Castration resistant prostate cancer
Requirements for the patient
To 100 Years
Male
Medical requirements
- 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.
- 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).
StudyPSMAcTION
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
Castration resistant prostate cancer
Requirements
To 100 YearsMale
Unique study IDclinicaltrials.gov
NCT06780670
