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

Phase 1
Completed
Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
Drug: AMG 340
Registration Number
NCT04740034
Lead Sponsor
Amgen
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
42
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.
  • Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (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. estimated glomerular filtration rate [eGFR] ≥ 50 mL/min, aspartate aminotransferase [AST]/alanine aminotransferase [ALT] ≤ 3 x upper limit of normal [ULN], hemoglobin [Hgb] ≥ 9 g/dL (without blood transfusion within 7 days from screening assessment), platelets ≥ 100,000 / mm^3 (without platelet transfusion within 7 days from screening assessment), absolute neutrophil count [ANC] ≥ 1500 / mm^3).
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Exclusion Criteria
  • Subject has been diagnosed with or treated for another malignancy within the past 2 years 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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Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Dose ExpansionAMG 340An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.
Dose EscalationAMG 340Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.
Primary Outcome Measures
NameTimeMethod
Area under the concentration-time curve within a dosing interval (AUC0-t) of AMG 3403 weeks
Number of subjects with treatment-emergent adverse events (TEAEs)From screening until 90 Days after end of treatment

Includes TEAEs, treatment-related TEAEs, serious TEAEs, and clinically significant changes from baseline in vital signs and clinical laboratory tests.

Maximum Observed Plasma Concentration of AMG 3403 weeks
Number of subjects with Dose-limiting toxicities (DLT)21 days
Time to Maximum Observed Plasma Concentration of AMG 3403 weeks
Secondary Outcome Measures
NameTimeMethod
Anti-tumor activity by objective response rate (ORR)24 months

Objective response rate is defined as the proportion of subjects with a confirmed partial or complete response to treatment

Overall survival (OS)24 months
Anti-tumor activity by progression free survival (PFS)24 months

Progression-free survival time is defined as the time from the first dose of AMG 340 to progression or death, whichever occurs first

Percentage of subjects that achieve a reduction of ≥ 30% in prostate specific antigen (PSA30)24 months
Percentage of subjects that achieve a reduction of ≥ 50% in prostate specific antigen (PSA50)24 months
Percentage of subjects that achieve a reduction of ≥ 70% in prostate specific antigen (PSA70)24 months
Anti-tumor activity by progression free survival (PFS) at 6 months6 months

Progression-free survival time is defined as the time from the first dose of AMG 340 to progression or death, whichever occurs first

Percentage of subjects that achieve a reduction of ≥ 90% in prostate specific antigen (PSA90)24 months
Time to progression24 months
Anti-tumor activity by duration of objective response (DOR)24 months

The duration of objective response for a subject is defined as the time from the initial objective response to disease progression or death, whichever occurs first

Time to symptomatic skeletal events (SSE)24 months
Prostate specific antigen (PSA) DOR based on PSA5024 months

Trial Locations

Locations (7)

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

Tennessee Oncology

🇺🇸

Nashville, Tennessee, United States

UCSF

🇺🇸

San Francisco, California, United States

Sarah Cannon Research Institute at HealthONE

🇺🇸

Denver, Colorado, United States

Florida Cancer Specialists

🇺🇸

Sarasota, Florida, United States

Thomas Jefferson University - Sidney Kimmel Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

Tulane Cancer Center

🇺🇸

New Orleans, Louisiana, United States

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