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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04702737




Registration number
NCT04702737
Ethics application status
Date submitted
7/01/2021
Date registered
11/01/2021
Date last updated
25/03/2024

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
To evaluate the safety and tolerability of Tarlatamab and will determine the maximum
tolerated dose (MTD) or recommended phase 2 dose (RP2D).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04702737
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