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Terminated/Withdrawn
Sponsor ID
TNB585.001

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

Sponsor ID
TNB585.001
Clinicaltrials.gov ID
NCT04740034
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
42
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of subjects with Dose-limiting toxicities (DLT)

Timeframe: 21 days

Number of subjects with treatment-emergent adverse events (TEAEs)

Timeframe: From screening until 90 Days after end of treatment

Maximum Observed Plasma Concentration of AMG 340

Timeframe: 3 weeks

Time to Maximum Observed Plasma Concentration of AMG 340

Timeframe: 3 weeks

Area under the concentration-time curve within a dosing interval (AUC0-t) of AMG 340

Timeframe: 3 weeks

Secondary Outcome Measures

Anti-tumor activity by objective response rate (ORR)

Timeframe: 24 months

Overall survival (OS)

Timeframe: 24 months

Anti-tumor activity by progression free survival (PFS)

Timeframe: 24 months

Anti-tumor activity by progression free survival (PFS) at 6 months

Timeframe: 6 months

Percentage of subjects that achieve a reduction of ≥ 30% in prostate specific antigen (PSA30)

Timeframe: 24 months

Percentage of subjects that achieve a reduction of ≥ 50% in prostate specific antigen (PSA50)

Timeframe: 24 months

Percentage of subjects that achieve a reduction of ≥ 70% in prostate specific antigen (PSA70)

Timeframe: 24 months

Percentage of subjects that achieve a reduction of ≥ 90% in prostate specific antigen (PSA90)

Timeframe: 24 months

Time to progression

Timeframe: 24 months

Anti-tumor activity by duration of objective response (DOR)

Timeframe: 24 months

Prostate specific antigen (PSA) DOR based on PSA50

Timeframe: 24 months

Time to symptomatic skeletal events (SSE)

Timeframe: 24 months

Locations

Location
Status
Contact Us
Location
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Status
Recruiting
Location
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Status
Recruiting
Location
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Status
Recruiting
Location
Tulane Cancer Center
New Orleans, Louisiana, United States, 70112
Status
Recruiting
Location
Thomas Jefferson University - Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Status
Recruiting
Location
UCSF
San Francisco, California, United States, 94158
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Prostate Cancer
    • Sex
    Assigned Male at Birth
    Trial Dates
    Apr 2021 - Jun 2024
    Inclusion and Exclusion Criteria
    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).
    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.