Protocol Title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Sponsor: Amgen Inc

Protocol Number: 201801

Key Criteria

Histologically or cytologically confirmed mCRPC
Bilateral orchiectomy or be on continuous androgen deprivation therapy with GnRH agonist/antagonist
T < 50 ng/dL or 1.7 nmol/L
Evidence of progressive disease
Excluded if
> Pure small cell, neuroendocrine carcinoma or any histology different from adenocarcinoma
> Anticancer/immune /radiation therapy within 4 weeks of starting first dose (excluding LHRH/GnRH analogues)
> Untreated CNS metastases or leptomeningeal disease
> History of or current autoimmune disease requiring immunosuppressive therapy
> Requiring chronic systemic corticosteroid therapy > 10 mg/day

Talking Points

  • Drug class: Monoclonal T cell engager antibody
    • Therapeutic context: Pts with mCRPC who have received prior treatment with 1 novel hormonal therapy and are refractory, failed taxane regimens or are deemed unsuitable for taxane regimen or have refused treatment with taxane
    • Duration: up to three years
    • Design:
      • Open label, multiple dose, multi cohort study
      • AMG 509 will be administered as monotherapy or in combination with abiraterone acetate, enzalutamide and docetaxel
      • As of 09/2023, AMG 509 is only being administered as monotherapy.
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