Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04740034




Registration number
NCT04740034
Ethics application status
Date submitted
1/02/2021
Date registered
5/02/2021

Titles & IDs
Public title
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Scientific 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
Secondary ID [1] 0 0
20210249
Secondary ID [2] 0 0
TNB585.001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 340

Experimental: Dose Escalation - Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.

Experimental: Dose Expansion - An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.


Treatment: Drugs: AMG 340
AMG 340 is a bispecific antibody targeting prostate-specific membrane antigen (PSMA) on tumor cells and CD3 on T-cells
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with Dose-limiting toxicities (DLT)
Timepoint [1] 0 0
21 days
Primary outcome [2] 0 0
Number of subjects with treatment-emergent adverse events (TEAEs)
Timepoint [2] 0 0
From screening until 90 Days after end of treatment
Primary outcome [3] 0 0
Maximum Observed Plasma Concentration of AMG 340
Timepoint [3] 0 0
3 weeks
Primary outcome [4] 0 0
Time to Maximum Observed Plasma Concentration of AMG 340
Timepoint [4] 0 0
3 weeks
Primary outcome [5] 0 0
Area under the concentration-time curve within a dosing interval (AUC0-t) of AMG 340
Timepoint [5] 0 0
3 weeks
Secondary outcome [1] 0 0
Anti-tumor activity by objective response rate (ORR)
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Overall survival (OS)
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Anti-tumor activity by progression free survival (PFS)
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Anti-tumor activity by progression free survival (PFS) at 6 months
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Percentage of subjects that achieve a reduction of = 30% in prostate specific antigen (PSA30)
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Percentage of subjects that achieve a reduction of = 50% in prostate specific antigen (PSA50)
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Percentage of subjects that achieve a reduction of = 70% in prostate specific antigen (PSA70)
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Percentage of subjects that achieve a reduction of = 90% in prostate specific antigen (PSA90)
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Time to progression
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Anti-tumor activity by duration of objective response (DOR)
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Prostate specific antigen (PSA) DOR based on PSA50
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
Time to symptomatic skeletal events (SSE)
Timepoint [12] 0 0
24 months

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/06/2024
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04740034