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Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
Trial Status: active
The primary objectives of this study are to evaluate the safety and tolerability of
xaluritamig administered as monotherapy or in combination with an oral
Gonadotropin-releasing Hormone (GnRH) antagonist in the neoadjuvant setting followed by
radical prostatectomy, and to evaluate the feasibility and safety of a radical
prostatectomy following xaluritamig administered as monotherapy or in combination with an
oral GnRH antagonist in the neoadjuvant setting.
Inclusion Criteria
Inclusion Criteria:
Participants are eligible to be included in the study only if all the following criteria
apply:
- Participants planned to undergo radical prostatectomy.
- Histologically or cytologically confirmed adenocarcinoma of the prostate at initial
biopsy, without neuroendocrine differentiation, signet cell, or small cell features.
Intermediate- or high-risk localized prostate cancer, defined as:
- Gleason score of 4+3 or higher AND initial PSA (iPSA) >10 OR
- Clinically advanced (cT3) on Magnetic Resonance Imaging (MRI) obtained within 3
months prior to screening AND/OR
- Positive locoregional lymph nodes as detected by prostate-specific membrane
antigen-positron emission tomography (PSMA-PET) scans OR ≤ 5 local lymph nodes
on MRI can be enrolled.
- Participants must have undergone a PSMA-PET (CT or MRI) scan within 3 months prior
to screening as part of the standard of care (SOC).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Prior treatment for participant's prostate cancer.
- Exception: Participants intended for enrollment in cohort B may have received an
oral GnRH antagonist up to 3 months prior to the start of screening.
- Any evidence of metastases outside of the surgical resection field identified by
conventional imaging or PSMA-PET scans.
- Confirmed history or current autoimmune disease or other diseases resulting in
permanent immunosuppression or requiring permanent immunosuppressive therapy.
- Participants with symptoms and/or clinical signs and/or radiographic signs that
indicate an acute and/or uncontrolled active systemic infection within 7 days prior
to the first dose of study treatment:
- Participant has known active infection requiring antibiotic treatment. Upon
completion of antibiotics and resolution of symptoms, the participant may be
considered eligible for the study from an infection standpoint.
- Recent history of arterial or venous thrombosis (eg, stroke, transient ischemic
attack, pulmonary embolism, or deep vein thrombosis) within 6 and 3 months prior to
the first dose of study treatment, respectively. Note: Participants with a history
of venous thrombosis must be on stable anti-coagulation.
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart
Association ≥ class II) within 12 months of first dose of xaluritamig with the
exception of ischemia or non-ST segment elevation myocardial infarction controlled
with stent placement more than 6 months prior to first dose of xaluritamig.
- Requirement for chronic systemic corticosteroid therapy unless stopped (with
adequate tapering) within 7 days prior to dosing.
- Currently receiving treatment in another investigational device or drug study, or
less than 4 weeks (since ending treatment on another investigational device or drug
study[ies]). Other investigational procedures and participation in observational
research studies while participating in this study are excluded with the exception
of investigational scans.
Additional locations may be listed on ClinicalTrials.gov for NCT06613100.