AMGEN ONCOLOGY CLINICAL TRIAL FINDER

Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With mCRPC
ModalityHLE BiTE® technology
MoleculeAMG 160
Malignancy(ies) Prostate cancer
Enrollment statusRecruiting
Brief descriptionA study to evaluate the safety and tolerability of AMG 160 in adult subjects with metastatic castration-resistant prostate cancer (mCRPC), and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
Outcome measuresSubject incidence of dose-limiting toxicity
ELIGIBILITY CRITERIA:
Age
18 Years and older (Adult, Older Adult)
ELIGIBILITY CRITERIA:
Sex
Male
ELIGIBILITY CRITERIA:
Healthy volunteers?
No
ELIGIBILITY CRITERIA:
Inclusion criteria
- Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/o
ELIGIBILITY CRITERIA:
Exclusion criteria
Exclusion Criteria:
- Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for >/= 30 days prior to randomization are eligible - Prior PSMA-targeted therapy Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
- Active autoimmune disease or any other diseases requiring immunosuppressive therapy while on study
Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose
NCT identifier03792841
URLhttps://ClinicalTrials.gov/show/NCT03792841