Study Details

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A Phase 1b Study of AMG509 in Subjects w/ High-risk Biochemical Recurrence of Prostate Cancer

This study is being carried out to learn more about administration of xaluritamig in people with high-risk biochemical recurrence (BCR) or sometimes referred to as nonmetastatic castration-sensitive prostate cancer (nmCSPC) after receiving definitive (primary) treatment.

Age & Gender

18 years ~ 99 years
Male

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

The study involves physical exams, vital signs, blood draws for labs and research, PET/CT scans, tumor biopsies, questionnaires, EKGs, adverse event assessments, and study drug treatment.

Incentives

Study medication

In-person visits:
22

Phone or online visits:
none

Total length of participation:
18 months

Looking for Specific Volunteers

Able to participate:

Initial biopsy showing histologically or cytologically confirmed adenocarcinoma of the prostate, without neuroendocrine differentiation, signet cell, or small cell features.
Prostate cancer initially treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both (eg, salvage radiotherapy), with curative intent.
Subjects must have undergone a specific type of PET scan (8Ga-PSMA-11 or a piflufolastat F18) during or within 3 months of screening.
Performance status of 0 to 1 based on ECOG criteria.
Adequate hematological, renal, hepatic, and cardiac organ function per values in protocol.

Not eligible if:

Present evidence of metastatic disease from CT or bone scan.
Received prior systemic biologic therapy, including immunotherapy, for prostate cancer.
History of another cancer within the past two years (with some exceptions).
Major surgery within 4 weeks of enrollment.
Known and detectable HIV infection, Hepatitis C or B infection.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Young Whang
Lineberger Comprehensive Cancer Center

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Prostate, Phase 1 Trials (all cancers))
Rare Diseases
Men's Health

IRB Number

24-1870

ClinicalTrials.gov

Not yet available