Clinical Trials List
Protocol Number20160323
NCT Number(ClinicalTrials.gov Identfier)NCT03319940
2021-11-15 - 2024-03-15
Phase I
Recruiting3
ICD-10D02.20
Carcinoma in situ of unspecified bronchus and lung
ICD-10D02.21
Carcinoma in situ of right bronchus and lung
ICD-10D02.22
Carcinoma in situ of left bronchus and lung
ICD-9231.2
Carcinoma in situ of bronchus and lung
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Amgen Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 張平穎 Division of Hematology & Oncology
- 陳佳宏 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
- 黃子權 Division of Hematology & Oncology
- 賴學緯 Division of Hematology & Oncology
- 陳宇欽 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
- 何景良 Division of Hematology & Oncology
- 吳宜穎 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李玫萱 Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
- KUAN-LI WU Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Linkou Chang Gung Medical Foundation
Taiwan National PI
張文震
Co-Principal Investigator
- Chih-Hsi Kuo Division of Thoracic Medicine
- 枋岳甫 Division of Thoracic Medicine
- Cheng-Ta Yang Division of Thoracic Medicine
- Ping-Chih Hsu Division of Thoracic Medicine
- Chih-Hung Chen Division of Thoracic Medicine
- 吳教恩 Division of Hematology & Oncology
- Chih-Hung Chen Division of Thoracic Medicine
- Shih-Hong Li Division of Thoracic Medicine
- 張境夫 Division of Hematology & Oncology
- Chih-Liang Wang Division of Thoracic Medicine
- 吳振德 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Small Cell Lung Carcinoma
Objectives
This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757 monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. AMG 757 will be administered as a short term intravenous (IV) infusion in subjects with small cell lung cancer. AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Test Drug
AMG 757
Active Ingredient
AMG 757
Dosage Form
Powder for solution for infusion, Solution for infusion
Dosage
1, 10, 25, 6.4
Endpoints
Primary Outcome Measures :
Number of participants with dose limiting toxicities (DLT) for all indications [ Time Frame: 6 months ]
Number of participants with treatment-emergent adverse events (AEs) for all indications [ Time Frame: 24 months ]
Number of participants with treatment-related AEs for all indications [ Time Frame: 24 months ]
Number of participants with clinically significant changes in vital signs for all indications [ Time Frame: 24 months ]
Number of participants with significant changes in ECG for all indications [ Time Frame: 24 months ]
Number of participants with significant changes in physical examinations for all indications [ Time Frame: 24 months ]
Number of participants with significant changes in clinical laboratory tests for all indications [ Time Frame: 24 months ]
Secondary Outcome Measures :
Maximum observed concentration (Cmax) following intravenous administration for all indications [ Time Frame: 24 months ]
Minimum observed concentration (Cmin) following intravenous administration for all indications [ Time Frame: 24 months ]
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications [ Time Frame: 24 months ]
Accumulation following multiple dosing for all indications [ Time Frame: 24 months ]
Half-life (t1/2) following intravenous administration for all indications [ Time Frame: 24 months ]
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for all indications [ Time Frame: 24 months ]
Duration of Response (DOR) for all indications [ Time Frame: 24 months ]
Time to Response (TTR) [ Time Frame: 24 months ]
9-month Progression-Free Survival (PFS) for all indications [ Time Frame: 9 months ]
9-month Overall Survival (OS) for all indications [ Time Frame: 9 months ]
Number of participants with dose limiting toxicities (DLT) for all indications [ Time Frame: 6 months ]
Number of participants with treatment-emergent adverse events (AEs) for all indications [ Time Frame: 24 months ]
Number of participants with treatment-related AEs for all indications [ Time Frame: 24 months ]
Number of participants with clinically significant changes in vital signs for all indications [ Time Frame: 24 months ]
Number of participants with significant changes in ECG for all indications [ Time Frame: 24 months ]
Number of participants with significant changes in physical examinations for all indications [ Time Frame: 24 months ]
Number of participants with significant changes in clinical laboratory tests for all indications [ Time Frame: 24 months ]
Secondary Outcome Measures :
Maximum observed concentration (Cmax) following intravenous administration for all indications [ Time Frame: 24 months ]
Minimum observed concentration (Cmin) following intravenous administration for all indications [ Time Frame: 24 months ]
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications [ Time Frame: 24 months ]
Accumulation following multiple dosing for all indications [ Time Frame: 24 months ]
Half-life (t1/2) following intravenous administration for all indications [ Time Frame: 24 months ]
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for all indications [ Time Frame: 24 months ]
Duration of Response (DOR) for all indications [ Time Frame: 24 months ]
Time to Response (TTR) [ Time Frame: 24 months ]
9-month Progression-Free Survival (PFS) for all indications [ Time Frame: 9 months ]
9-month Overall Survival (OS) for all indications [ Time Frame: 9 months ]
Inclution Criteria
Inclusion Criteria:
Subject has provided informed consent prior to initiation of any study-specific activities/procedures
Age greater than or equal to 18 years old at the time of signing the informed consent
Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC):
Part A, C, D, E, F, and G: RR SCLC who progressed or recurred following platinum-based regimen;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Subjects with treated brain metastases are eligible provided they meet defined criteria
Adequate organ function as defined in protocol
Subject has provided informed consent prior to initiation of any study-specific activities/procedures
Age greater than or equal to 18 years old at the time of signing the informed consent
Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC):
Part A, C, D, E, F, and G: RR SCLC who progressed or recurred following platinum-based regimen;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Subjects with treated brain metastases are eligible provided they meet defined criteria
Adequate organ function as defined in protocol
Exclusion Criteria
Exclusion Criteria:
History of other malignancy within the past 2 years prior to first dose of AMG 757 with exceptions
Major surgery within 28 days of first dose AMG 757
Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease
Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757
Exceptions:
Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1
Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
Subjects who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents.
Has evidence of interstitial lung disease or active, non-infectious pneumonitis
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of AMG 757
Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
No evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If history of SARS-CoV-2, no acute symptoms of coronavirus disease 2019 (COVID-19) within14 days prior to first dose of investigational product (counted from day of positive test for asymptomatic subjects)
History of other malignancy within the past 2 years prior to first dose of AMG 757 with exceptions
Major surgery within 28 days of first dose AMG 757
Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease
Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757
Exceptions:
Subjects who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1
Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
Subjects who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents.
Has evidence of interstitial lung disease or active, non-infectious pneumonitis
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of AMG 757
Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
No evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If history of SARS-CoV-2, no acute symptoms of coronavirus disease 2019 (COVID-19) within14 days prior to first dose of investigational product (counted from day of positive test for asymptomatic subjects)
The Estimated Number of Participants
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Taiwan
20 participants
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Global
332 participants
