Trial record 1 of 2 for:
NCT03319940
Study Evaluating Safety, Tolerability and PK of AMG 757 in Adults With Small Cell Lung Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03319940 |
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Recruitment Status :
Recruiting
First Posted : October 24, 2017
Last Update Posted : May 18, 2023
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Brief Summary:
A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with Small Cell Lung Cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Small Cell Lung Carcinoma | Drug: AMG 757 Drug: Pembrolizumab Drug: CRS Mitigation Strategies | Phase 1 |
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)
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 382 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 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 in subjects with Small Cell Lung Cancer. The dose exploration phases of the study will estimate the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of AMG 757 either as monotherapy or in combination with pembrolizumab. This will be followed by dose expansion phase to confirm RP2D and to obtain further safety and efficacy data. |
| Masking: | None (Open Label) |
| Masking Description: | The patient, investigator, investigative staff, medical monitor and care provider will not be masked for the study. |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer |
| Actual Study Start Date : | December 26, 2017 |
| Estimated Primary Completion Date : | September 28, 2024 |
| Estimated Study Completion Date : | March 27, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part A
AMG 757 Monotherapy
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Drug: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3) |
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Experimental: Part C
AMG 757 with Pembrolizumab
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Drug: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3) Drug: Pembrolizumab Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2 |
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Experimental: Part D
AMG 757 with additional cytokine release syndrome (CRS) mitigation strategies
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Drug: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3) Drug: CRS Mitigation Strategies Subjects will be treated with one of the CRS mitigation strategies. |
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Experimental: Part E
AMG 757 administration with 24-hour monitoring
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Drug: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3) |
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Experimental: Part F
AMG 757 administered in outpatient infusion centers with 8-hour monitoring Optional wearable digital device substudy (US sites only) |
Drug: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3) |
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Experimental: Part G
AMG 757 additional dosing schedule Optional wearable digital device substudy (US sites only) |
Drug: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3) |
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 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319940
Contacts
| Contact: Amgen Call Center | 866-572-6436 | medinfo@amgen.com |
Locations
Show 38 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
Publications:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT03319940 |
| Other Study ID Numbers: |
20160323 |
| First Posted: | October 24, 2017 Key Record Dates |
| Last Update Posted: | May 18, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. |
| Access Criteria: | Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below. |
| URL: | https://www.amgen.com/datasharing |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Amgen:
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Half Life Extended (HLE) Bispecific T cell engager (BiTE®) Delta-like protein 3 (DLL3) |
Additional relevant MeSH terms:
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Small Cell Lung Carcinoma Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Pembrolizumab AMG 757 Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |