Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-585, 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 TNB-585 monotherapy in subjects with mCRPC.

Official Title

A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-585, 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 TNB-585

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

Details

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