A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

Neuroendocrine Prostate Cancer Clinical Trial

— DeLLpro-300  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04702737
• Other study ID #: 20200040
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 10, 2021
• Est. completion date: August 23, 2025

Study information

• Verified date: March 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: August 23, 2025
• Est. primary completion date: August 23, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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).

Related Conditions & MeSH terms

• Neuroendocrine Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.

Locations

Country	Name	City	State
Australia	Chris OBrien Lifehouse	Camperdown	New South Wales
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Austria	Medizinische Universitaet Graz	Graz
Austria	Ordensklinikum Linz Elisabethinen	Linz
Austria	Landeskrankenhaus Salzburg	Salzburg
Belgium	Universitair Ziekenhuis Gent	Gent
France	Gustave Roussy	Villejuif Cedex
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Netherlands	Erasmus Medisch Centrum	Rotterdam
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona	Cataluña
United Kingdom	Royal Marsden Hospital	Sutton
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	University of Chicago	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Community Health Network MD Anderson Cancer Center - North	Indianapolis	Indiana
United States	Weill Cornell Medical College	New York	New York
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Washington University	Saint Louis	Missouri
United States	University of California at San Francisco Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  France,  Japan,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs)		Day 1 to 12 months
Primary	Number of Participants who Experience One or More Treatment-related Adverse Events		Day 1 to 12 months
Primary	Number of Participants who Experience a Clinically Significant Change from Baseline in Vital Signs		Baseline to 12 months
Primary	Number of Participants who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements		Baseline to 12 months
Primary	Number of Participants who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests		Baseline to 12 months
Primary	Number of Participants who Experience Dose Limiting Toxicities (DLTs)		Baseline to 12 months
Secondary	Objective Response (OR)	OR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.	Baseline to 12 months
Secondary	Duration of Response (DOR)		Baseline to 12 months
Secondary	Progression-free Survival (PFS)		Baseline to 12 months
Secondary	Overall Survival (OS)		Baseline to 12 months
Secondary	Disease Control Rate (DCR)		Baseline to 12 months
Secondary	Maximum Serum Concentration (Cmax) of Tarlatamab		Baseline to 12 months
Secondary	Minimum Serum Concentration (Cmin) of Tarlatamab		Baseline to 12 months
Secondary	Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab		Baseline to 12 months
Secondary	Accumulation Ratio of Tarlatamab		Baseline to 12 months
Secondary	Half-life (t1/2) of Tarlatamab		Baseline to 12 months

External Links

•   AmgenTrials clinical trials website