This is a phase 2a, open label, single arm, multi-site study of xaluritamig in mCRPC patients following treatment with ≥1 ARPI, taxane chemotherapy (if eligible) and stable or partial PSA response following 2 cycles of lutetium 177 vipivotide tetraxetan.
Participants will continue treatment until clinical or radiographic progression of disease, withdrawal, or toxicity requiring discontinuation of therapy. All participants will be evaluated for overall response per RECIST v1.1,8 radiographic progression free survival (rPFS) by Prostate Cancer Working Group 3 (PCWG3) criteria, and PSA response. Approximately 30 participants will be enrolled. There is no data on response with alternative treatments following lutetium 177 vipivotide tetraxetan against which to benchmark the response rate. This phase 2a study will serve as an exploratory pilot to determine if a larger phase 2b study is warranted in this setting.
18 years of age and above
Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
Prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L).
Received ≥1 novel ARPI (e.g., enzalutamide, darolutamide, apalutamide and/or abiraterone).
Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments in the judgment of the site Principal Investigator (PI). Participants with prior history of malignancy that have been adequately treated and who have been disease-free for > 3 years are eligible, as are subjects with adequately treated non-melanoma skin cancer or superficial bladder cancer.
Requirement for chronic systemic corticosteroid therapy (prednisone dose >10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-TNFα therapies) unless stopped (with adequate tapering) within 7 days prior to dosing. Corticosteroid treatment for adverse event management as described in Section 6.1.10 is allowed.
Previous PSMA-targeted radioligand therapy, aside from treatment with 2 cycles of lutetium 177 vipivotide tetraxetan, is not allowed.
Prior PSMA radioligand therapy within 6 weeks of first dose of study treatment.
Thomas Jefferson University
Lead sponsor
Prostate Cancer Clinical Trials Consortium
Collaborator
Amgen
Collaborator