Study on JSB462 (Luxdegalutamide) and Lutetium (177Lu) Vipivotide Tetraxetan for Treating Advanced Prostate Cancer
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT07047118
This clinical trial is testing a new combination of treatments, JSB462 and Lutetium (177Lu) Vipivotide Tetraxetan, to see if they are safe and effective for men with advanced prostate cancer that has spread and is resistant to standard hormone therapy.
Patient Parameters
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Program Overview
The purpose of this Phase II study is to evaluate how well a combination of two treatments, JSB462 (luxdegalutamide) and Lutetium (177Lu) Vipivotide Tetraxetan (AAA617), works in treating men with metastatic castration-resistant prostate cancer (mCRPC). The study will compare this combination to AAA617 alone. Participants must have previously tried at least one hormone therapy and up to two chemotherapy treatments. The study will help determine the best dose for future research.
Description
The study includes several stages: a screening period, a randomization period, a treatment period, and follow-up periods for safety and long-term monitoring.
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Screening and Randomization: Participants will be screened to ensure they meet the study criteria. Once enrolled, they will be randomly assigned to receive either the combination treatment or the control treatment.
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Treatment: Participants will start taking JSB462 by mouth daily from the first day of randomization. AAA617 will be given through an IV every six weeks, up to six times, starting from the first day of the treatment period. Treatment will continue until the cancer progresses, side effects become too severe, or the participant or doctor decides to stop.
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Follow-Up: After stopping treatment, participants will have a safety follow-up visit about 30 days later. Long-term follow-up will continue to collect information on safety, effectiveness, and survival.
The study aims to gather comprehensive data on how well the combination treatment works and how safe it is for patients.
Eligibility Criteria
Inclusion Criteria
- Men with confirmed prostate cancer that has spread to bones or other organs.
- Must be in relatively good health with an ECOG performance status of 0 to 2.
- Must have at least one detectable tumor on recent scans.
- Must test positive on a specific PET/CT scan.
- Must have tried at least one advanced hormone therapy.
- Can have had up to two chemotherapy treatments.
- Can participate if eligible for other treatments like PARPi or immune checkpoint inhibitors and have tried them before.
Exclusion Criteria
- Cannot have had previous treatment with any radioligand therapy (RLT).
- Cannot have had treatment with a drug that targets androgen receptors by degrading proteins.
- Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| XCancer Omaha LLC | 68130 | Omaha | Nebraska |
| NYU Laura and Isaac Perlmutter Cancer Center | 10016 | New York | New York |
| Univ of Pittsburgh Cancer Institute | 15232 | Pittsburgh | Pennsylvania |
| Urology San Antonio | 78229 | San Antonio | Texas |
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