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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
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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
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Secondary ID [1]
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20200040
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Universal Trial Number (UTN)
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Trial acronym
DeLLpro-300
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional(has expanded access)
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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Timepoint [1]
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Day 1 to 12 months
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Primary outcome [2]
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Number of Participants who Experience One or More Treatment-related Adverse Events
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Assessment method [2]
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Timepoint [2]
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Day 1 to 12 months
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Primary outcome [3]
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Number of Participants who Experience a Clinically Significant Change from Baseline in Vital Signs
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Assessment method [3]
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Timepoint [3]
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Baseline to 12 months
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Primary outcome [4]
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Number of Participants who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
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Assessment method [4]
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Timepoint [4]
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Baseline to 12 months
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Primary outcome [5]
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Number of Participants who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests
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Assessment method [5]
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Timepoint [5]
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Baseline to 12 months
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Primary outcome [6]
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Number of Participants who Experience Dose Limiting Toxicities (DLTs)
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Assessment method [6]
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Timepoint [6]
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Baseline to 12 months
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Secondary outcome [1]
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Objective Response (OR)
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Assessment method [1]
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OR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.
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Timepoint [1]
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Baseline to 12 months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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Timepoint [2]
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Baseline to 12 months
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Secondary outcome [3]
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Progression-free Survival (PFS)
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Assessment method [3]
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Timepoint [3]
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Baseline to 12 months
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Timepoint [4]
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Baseline to 12 months
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Secondary outcome [5]
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Disease Control Rate (DCR)
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Assessment method [5]
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Timepoint [5]
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Baseline to 12 months
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Secondary outcome [6]
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Maximum Serum Concentration (Cmax) of Tarlatamab
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Assessment method [6]
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Timepoint [6]
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Baseline to 12 months
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Secondary outcome [7]
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Minimum Serum Concentration (Cmin) of Tarlatamab
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Assessment method [7]
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Timepoint [7]
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Baseline to 12 months
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Secondary outcome [8]
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Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab
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Assessment method [8]
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Timepoint [8]
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Baseline to 12 months
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Secondary outcome [9]
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Accumulation Ratio of Tarlatamab
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Assessment method [9]
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Timepoint [9]
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Baseline to 12 months
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Secondary outcome [10]
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Half-life (t1/2) of Tarlatamab
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Assessment method [10]
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Timepoint [10]
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Baseline to 12 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
23/08/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
41
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Chris OBrien Lifehouse - Camperdown
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Georgia
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Indiana
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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State/province [7]
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New York
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Country [8]
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United States of America
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State/province [8]
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North Carolina
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Country [9]
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United States of America
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State/province [9]
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Ohio
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Country [10]
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United States of America
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State/province [10]
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Texas
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Country [11]
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Austria
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State/province [11]
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Graz
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Country [12]
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Austria
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State/province [12]
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Linz
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Country [13]
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Austria
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State/province [13]
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Salzburg
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Country [14]
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Belgium
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State/province [14]
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Gent
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Country [15]
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France
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State/province [15]
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Villejuif Cedex
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Country [16]
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Japan
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State/province [16]
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Tokyo
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Country [17]
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Netherlands
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State/province [17]
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Rotterdam
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Country [18]
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Spain
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State/province [18]
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Cataluña
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Country [19]
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United Kingdom
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State/province [19]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04702737
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04702737
Download to PDF