LuX: Xaluritamig in Participants With Metastatic Castrate Resistant Prostate Cancer and Suboptimal Response to Lutetium 177 Vipivotide Tetraxetan

Sponsor
Thomas Jefferson University
Study ID
NCT07737925
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Xaluritamig — DRUG
    short-term IV infusion

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2030
Completion
Oct 31, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Xaluritamig
    Participants with metastatic castration-resistant prostate cancer (mCRPC) will be randomized to receive Xaluritamig as an intravenous (IV) infusion.

Primary Outcome Measure

Proportion of Participants who achieve Partial or Complete Response or PSA90 [ Time Frame: Baseline to 24 weeks ]

Central Contacts

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