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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
Date last updated
1/10/2024

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
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.
Trial website
https://clinicaltrials.gov/study/NCT04740034
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04740034