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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210415

Registered date:08/11/2021

A Study of Tarlatamab in Participants With Neuroendocrine Prostate Cancer (DeLLpro-300)

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedNeuroendocrine Prostate Cancer
Date of first enrollment10/06/2021
Target sample size60
Countries of recruitmentU.S.,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,France,Japan,Spain,Japan,United Kingdom,Japan
Study typeInterventional
Intervention(s)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. Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Experimental: Part 2: Dose Expansion Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study. Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion. Experimental: Part 2: Biomarker Expansion Participants who test delta-like protein 3 (DLL3) positive will receive a dose of Tarlatamab determined by Amgen study 20160323 (NCT03319940). Intervention: Drug: Tarlatamab Tarlatamab will be administered as an intravenous (IV) infusion.

Outcome(s)

Primary Outcome1. Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to 12 months ] 2. Number of Participants who Experience One or More Treatment-related Adverse Events [ Time Frame: Day 1 to 12 months ] 3. Number of Participants who Experience a Clinically Significant Change from Baseline in Vital Signs [ Time Frame: Baseline to 12 months ] 4. Number of Participants who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements [ Time Frame: Baseline to 12 months ] 5. Number of Participants who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests [ Time Frame: Baseline to 12 months ] 6. Number of Participants who Experience Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline to 12 months ]
Secondary Outcome1. Objective Response (OR) [ Time Frame: Baseline to 12 months ] OR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications. 2. Duration of Response (DOR) [ Time Frame: Baseline to 12 months ] 3. Progression-free Survival (PFS) [ Time Frame: Baseline to 12 months ] 4. Overall Survival (OS) [ Time Frame: Baseline to 12 months ] 5. Disease Control Rate (DCR) [ Time Frame: Baseline to 12 months ] 6. Maximum Serum Concentration (Cmax) of Tarlatamab [ Time Frame: Baseline to 12 months ] 7. Minimum Serum Concentration (Cmin) of Tarlatamab [ Time Frame: Baseline to 12 months ] 8. Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab [ Time Frame: Baseline to 12 months ] 9. Accumulation Ratio of Tarlatamab [ Time Frame: Baseline to 12 months ] 10. Half-life (t1/2) of Tarlatamab [ Time Frame: Baseline to 12 months ]

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderMale
Include criteriaPart 1: Dose Exploration and Part 2: Dose Expansion: 1. Participant has provided informed consent prior to initiation of any study specific activities/procedures. 2. Men aged >= 18 years at time of signing the informed consent. 3. Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) defined by histological, immunohistochemistry, or genomic analyses of baseline tumor tissue (by local assessment) or circulating tumor DNA (ctDNA) (by local assessment) as per protocol 4. At least 1 line of prior systemic treatment per protocol. 5. 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 6. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Prostate Cancer Working Group 3 (PCWG3) modifications 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 2 8. Participants with treated brain metastases are eligible provided they meet defined criteria 9. Adequate organ function as defined in protocol Part 2: Biomarker Expansion: Participants are eligible to be included in Part 2: Biomarker Expansion of the study only if all of the following criteria apply: 1. Participants aged >= 18 years at time of signing the informed consent. 2. Metastatic de novo or treatment-emergent NEPC not amenable to curative treatment with the following characteristics: - Neuroendocrine prostate carcinoma defined as either poorly differentiated carcinoma with similar histology as small cell lung cancer (SCLC), mixed tumors with both prostate adenocarcinoma and small cell morphologies, or cancers with high clinical or pathologicalsuspicion for NEPC. - Tumor must be positive for DLL3 expression according to central pathology review. 3. Progressed on at least 1 line of prior systemic treatment with a platinum containing agent - Exception: participants may also be included if the aforementioned therapeutic options were medically not appropriate for them. In these cases, the reason(s) why required prior therapies were medically not appropriate should be documented in the participant's electronic case report form (eCRF). 4. Measurable disease per RECIST 1.1 per PCWG3 modifications 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of >= 2 6. Minimum life expectancy of 12 weeks, in the opinion of the investigator 7. Participants with treated brain metastases are eligible provided they meet the following criteria: - Definitive treatment was completed at least 2 weeks prior to the first planned dose of study treatment (stereotactic radiosurgery at least 7 days prior to first planned dose of study treatment) - At least 7 days prior to treatment: any central nervous system (CNS) disease is clinically stable, participant is off steroids for CNS disease (unless steroids are indicated for a reason unrelated to CNS disease), and participant is off or on stable doses of anti-epileptic drugs.
Exclude criteriaPart 1: Dose Exploration, Part 2: Dose Expansion and Part 2: Biomarker Expansion : 1. 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 2. History or presence of hematological malignancies unless curatively treated with no evidence of disease >= 2 years 3. Untreated or symptomatic brain metastases and leptomeningeal disease 4. Anti-tumor therapy within 28 days of study day 1; concurrent use of hormone deprivation therapy for hormone refractory prostate 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 5. 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 6. Active autoimmune disease requiring systemic treatment within the past 12 months 7. Known positive test for human immunodeficiency virus (HIV) or hepatitis 8. 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) 9. History of hypophysitis or pituitary dysfunction 10. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 11. Participants on prior delta-like protein 3 (DLL3)-targeted therapy may be eligible if discussed with Amgen medical monitor prior to enrollment 12. 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 Information

Contact

Public contact
Name Local Contact
Address Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo Tokyo Japan 107-6239
Telephone +81-80-7217-8592
E-mail clinicaltrials_japan@amgen.com
Affiliation Amgen K.K.
Scientific contact
Name Shuzo Tagashira
Address Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo Tokyo Japan 107-6239
Telephone +81-80-7217-8592
E-mail clinicaltrials_japan@amgen.com
Affiliation Amgen K.K.