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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04702737




Registration number
NCT04702737
Ethics application status
Date submitted
7/01/2021
Date registered
11/01/2021

Titles & IDs
Public title
A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
Scientific title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager AMG 757 in Subjects With De Novo or Treatment Emergent Neuroendocrine Prostate Cancer
Secondary ID [1] 0 0
20200040
Universal Trial Number (UTN)
Trial acronym
DeLLpro-300
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Tarlatamab

Experimental: Part 1: Dose Exploration - The maximum tolerated dose (MTD) will be estimated using isotonic regression (Ji et al, 2010). The recommended phase 2 dose (RP2D) may be identified based on emerging safety data prior to reaching an MTD.

Experimental: Part 2: Dose Expansion - Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study.


Treatment: Drugs: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Day 1 to 12 months
Primary outcome [2] 0 0
Number of Participants who Experience One or More Treatment-related Adverse Events
Timepoint [2] 0 0
Day 1 to 12 months
Primary outcome [3] 0 0
Number of Participants who Experience a Clinically Significant Change from Baseline in Vital Signs
Timepoint [3] 0 0
Baseline to 12 months
Primary outcome [4] 0 0
Number of Participants who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Timepoint [4] 0 0
Baseline to 12 months
Primary outcome [5] 0 0
Number of Participants who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Timepoint [5] 0 0
Baseline to 12 months
Primary outcome [6] 0 0
Number of Participants who Experience Dose Limiting Toxicities (DLTs)
Timepoint [6] 0 0
Baseline to 12 months
Secondary outcome [1] 0 0
Objective Response (OR)
Timepoint [1] 0 0
Baseline to 12 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Baseline to 12 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
Baseline to 12 months
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Baseline to 12 months
Secondary outcome [5] 0 0
Disease Control Rate (DCR)
Timepoint [5] 0 0
Baseline to 12 months
Secondary outcome [6] 0 0
Maximum Serum Concentration (Cmax) of Tarlatamab
Timepoint [6] 0 0
Baseline to 12 months
Secondary outcome [7] 0 0
Minimum Serum Concentration (Cmin) of Tarlatamab
Timepoint [7] 0 0
Baseline to 12 months
Secondary outcome [8] 0 0
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab
Timepoint [8] 0 0
Baseline to 12 months
Secondary outcome [9] 0 0
Accumulation Ratio of Tarlatamab
Timepoint [9] 0 0
Baseline to 12 months
Secondary outcome [10] 0 0
Half-life (t1/2) of Tarlatamab
Timepoint [10] 0 0
Baseline to 12 months

Eligibility
Key inclusion criteria
Inclusion Criteria (Part 1: Dose Exploration and Part 2: Dose Expansion):

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Men aged = 18 years at time of signing the informed consent.
* Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) defined by histology, immunohistochemistry, or genomic analyses of baseline tumor tissue (by local assessment) or circulating tumor DNA (ctDNA) (by local assessment) as per protocol
* At least 1 line of prior systemic treatment per protocol.
* Participants with treatment-emergent NEPC or de novo NEPC with histologic evidence of prostate cancer with neuroendocrine differentiation without a history of bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue therapy during the course of protocol therapy
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Prostate Cancer Working Group 3 (PCWG3) modifications
* Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2
* Participants with treated brain metastases are eligible provided they meet defined criteria
* Adequate organ function as defined in protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria (Part 1: Dose Exploration and Part 2: Dose Expansion):

* History of other malignancy within the past 2 years, with exceptions:

* Malignancy treated with curative intent and with no known active disease present for = 2 years before enrollment and felt to be at low risk for recurrence by the treating physician
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
* Adequately treated non-muscle invasive urothelial carcinoma
* History or presence of hematological malignancies unless curatively treated with no evidence of disease = 2 years
* Untreated or symptomatic brain metastases and leptomeningeal disease
* Anti-tumor therapy within 28 days of study day 1; concurrent use of hormone deprivation therapy for hormone refractory prostate cancer is permitted; participants on a stable bisphosphonate or denosumab prior to study day 1 are eligible

Exceptions:

* Participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicities have resolved to Grade = 1
* Prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
* Participants who received androgen signaling inhibitor are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade = 1

* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior study day 1
* Active autoimmune disease requiring systemic treatment within the past 2 years
* Known positive test for human immunodeficiency virus (HIV) or hepatitis
* Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade 0 or 1 (with the exception of alopecia or toxicities that are stable and well-controlled)
* History of hypophysitis or pituitary dysfunction
* Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Participants on prior delta-like ligand 3 (DLL3)-targeted therapy may be eligible if discussed with Amgen Medical Monitor prior to enrollment
* Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection unless agreed upon with Medical Monitor and with no acute symptoms of coronavirus disease 2019 (COVID19) disease within 14 days prior to first dose of investigational product (counted from day of positive test for asymptomatic participants).

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/08/2025
Actual
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Austria
State/province [11] 0 0
Graz
Country [12] 0 0
Austria
State/province [12] 0 0
Linz
Country [13] 0 0
Austria
State/province [13] 0 0
Salzburg
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
France
State/province [15] 0 0
Villejuif Cedex
Country [16] 0 0
Japan
State/province [16] 0 0
Tokyo
Country [17] 0 0
Netherlands
State/province [17] 0 0
Rotterdam
Country [18] 0 0
Spain
State/province [18] 0 0
Cataluña
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Sutton

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)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


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/NCT04702737