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NCT07140900Phase 1RECRUITING

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

Study Summary

The main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.

Conditions
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions / Drugs
XaluritamigDarolutamideAbiraterone
View on ClinicalTrials.gov ↗
Sponsor
AMGN
Amgen Inc
Biologics
F35/100
Study Details
Enrollment60 participants
Primary Completion—
Lead SponsorAmgen
Data Retrieved2026-04-13 18:29:34.157483+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 60 participants
Sponsor Catalyst Profile

Amgen Inc (AMGN) is the sponsoring company for this trial. BiotechSign currently grades this company F (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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