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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03792841




Registration number
NCT03792841
Ethics application status
Date submitted
2/01/2019
Date registered
3/01/2019
Date last updated
8/08/2019

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With mCRPC
Scientific title
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager AMG 160 in Subjects With Metastatic Castration-resistant Prostate Cancer
Secondary ID [1] 0 0
20180101
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
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 160

Experimental: AMG 160 Treatment - AMG 160 is administered intravenously at different dose levels.


Treatment: Drugs: AMG 160
Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of dose-limiting toxicity - Number of dose limiting toxicities
Timepoint [1] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
- Subject has provided informed consent prior to initiation of any study-specific
activities/procedures

- Subjects with histologically or cytologically confirmed mCRPC who are refractory to a
novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have
failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically
unsuitable to be treated with a taxane regimen or have actively refused treatment with
a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the
non-metastatic CRPC setting

- Subject should have undergone bilateral orchiectomy or should be on continuous
androgen-deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH)
agonist or antagonist

- Total serum testosterone </= 50 ng/dL or 1.7 nmol/L

- Evidence of progressive disease, defined as 1 or more PCWG3 criteria: PSA level >/=1
ng/mL that has increased on at least 2 successive occasions at least 1 week apart,
nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications,
and/or appearance of 2 or more new lesions in bone scan
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not
including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue
(agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for
>/= 30 days prior to randomization are eligible

- Prior PSMA-targeted therapy

- Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord
compression

- Active autoimmune disease or any other diseases requiring immunosuppressive therapy
while on study

- Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or
equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis
factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Randwick
Recruitment hospital [3] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Salzburg
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles

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

Ethics approval
Ethics application status

Summary
Brief summary
A study to evaluate the safety and tolerability of AMG 160 in adult subjects with metastatic
castration-resistant prostate cancer (mCRPC), and determine the maximum tolerated dose (MTD)
or recommended phase 2 dose (RP2D).
Trial website
https://clinicaltrials.gov/show/NCT03792841
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
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03792841