Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Lawrence Fong
Headshot of Lawrence Fong
Lawrence Fong

Description

Summary

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of AMG 340 monotherapy in subjects with mCRPC.

Official Title

A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AMG 340, a Bispecific Antibody Targeting PSMA in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

Keywords

Metastatic Castration-resistant Prostate Cancer Prostate specific membrane antigen PSMA Prostate cancer Metastatic Castrate-resistant Prostatic Neoplasms AMG 340

Eligibility

You can join if…

Open to males ages 18 years and up

  • Pathologically confirmed prostatic adenocarcinoma.
  • History of metastatic disease.
  • Chemically or surgically castrate.
  • Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.
  • HIV, HBV, and/or HCV-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Subject must have adequate heart, liver, bone marrow and kidney function (e.g. eGFR ≥ 30 mL/min, AST/ALT ≤ 3 x ULN, Hgb ≥ 9 g/dL, Plt ≥ 100,000 / mm3, ANC ≥ 1500 / mm3).

You CAN'T join if...

  • Subject has been diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
  • History of neuroendocrine differentiation in the subject's disease.
  • Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.
  • Subject has clinically significant CNS pathology.
  • Subject requires chronic immunosuppressive therapy.
  • Subject has a history of major cardiac abnormalities.

Locations

  • UCSF accepting new patients
    San Francisco California 94158 United States
  • Sarah Cannon Research Institute at HealthONE accepting new patients
    Denver Colorado 80218 United States

Lead Scientist at UCSF

  • Lawrence Fong
    Lawrence Fong, M.D. is the Efim Guzik Distinguished Professor in Cancer Biology in the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, where he leads the Cancer Immunotherapy Program. He also co-directs the Parker Institute of Cancer Immunotherapy at UCSF and co-leads the Cancer Immunity and Immunotherapy Program in the Cancer Center.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
ID
NCT04740034
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated