Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorAmgen
About this trial
The primary objective of this trial is to determine the safety profile of xaluritamig at the proposed regimen in adult participants with metastatic castration-resistant prostate cancer (mCRPC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.
mCRPC with ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scintigraphy imaging obtained within 28 days prior to enrollment.
Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
Soft tissue progression defined as an increase ≥ 20% and an absolute increase of ≥ 5 mm in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
Disqualifiers
History of central nervous system metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.
History of allergic reactions or acute hypersensitivity reactions to the components of the trial therapies and their analogs. Participants with known contraindications to high-dose corticosteroids are also excluded.
History of malignancy that is expected to alter life expectancy or may interfere with disease assessments. Participants with prior history of malignancy that have been adequately treated and who have been disease-free for >3 years are eligible, as are participants with adequately treated non-melanoma skin cancer or superficial bladder cancer.
Active autoimmune disease that has required systemic treatment (except physiologic replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on trial.
Trial design
Design model
Single group
Treatments tested in this trial
Xaluritamig
DrugParticipants will receive xaluritamig via short-term intravenous (IV) infusion.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Xaluritamig Proposed RegimenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Treatment-emergent Adverse Events
This will include treatment-emergent adverse events, serious adverse events, treatment-related adverse events, and fatal adverse events.
Time frame
Up to 3.6 YearSecondary outcomes
1
Maximum Plasma Concentration (Cmax) of Xaluritamig
Time frame
Up to 1 Year2
Time to Cmax (tmax) of Xaluritamig
Time frame
Up to 1 Year3
Accumulation Ratio (AR) Following Multiple Doses of Xaluritamig
Time frame
Up to 1 Year4
Serum Concentration Before Dosing (Ctrough) of Xaluritamig
Time frame
Up to 1 Year Source ClinicalTrials.gov