A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    130
  • sponsor
    Amgen
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Updated on 25 July 2022
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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.

Details
Condition Metastatic Castration-resistant Prostate Cancer
Treatment TNB-585, AMG 340
Clinical Study IdentifierNCT04740034
SponsorAmgen
Last Modified on25 July 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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