Description:
A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with
Small Cell Lung Cancer
Title
- Brief Title: Study Evaluating Safety, Tolerability and PK of AMG 757 in Adults With Small Cell Lung Cancer
- Official Title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
20160323
- NCT ID:
NCT03319940
Conditions
- Small Cell Lung Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
AMG 757 | | Part A or Part B |
Pembrolizumab | | Part C |
CRS Mitigation Strategies | | Part D |
Purpose
A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with
Small Cell Lung Cancer
Detailed 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. 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)
Trial Arms
Name | Type | Description | Interventions |
---|
Part A or Part B | Experimental | AMG 757 Monotherapy | |
Part C | Experimental | AMG 757 with Pembrolizumab | |
Part D | Experimental | AMG 757 with additional cytokine release syndrome (CRS) mitigation strategies | - AMG 757
- CRS Mitigation Strategies
|
Part E | Experimental | AMG 757 administration with 24-hour monitoring | |
Part F | Experimental | AMG 757 administered in outpatient infusion centers with 8-hour monitoring. | |
Eligibility 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 and F: RR SCLC who progressed or recurred following platinum-based
regimen;
- Part B: ED SCLC with ongoing clinical benefit (stable disease [SD], partial response
[PR], or complete response [CR]) following no more than 6 cycles of first-line
platinum-based chemotherapy with the last dose of chemotherapy greater than or equal
to 28 days prior to the study day 1 (first-line consolidation setting)
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with dose limiting toxicities (DLT) for all indications |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Maximum observed concentration (Cmax) following intravenous administration for all indications |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Minimum observed concentration (Cmin) following intravenous administration for all indications |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Accumulation following multiple dosing for all indications |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Half-life (t1/2) following intravenous administration for all indications |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for all indications |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) for all indications |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Time to Response (TTR) |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | 9-month Progression-Free Survival (PFS) for all indications |
Time Frame: | 9 months |
Safety Issue: | |
Description: | |
Measure: | 9-month Overall Survival (OS) for all indications |
Time Frame: | 9 months |
Safety Issue: | |
Description: | |
Measure: | Relapse Free Survival (RFS) for subjects with ED SCLC with ongoing clinical benefit following no more than 6 cycles of platinum-based chemotherapy in monotherapy arm only |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Amgen |
Trial Keywords
- Half Life Extended (HLE) Bispecific T cell engager (BiTE®)
- Delta-like protein 3 (DLL3)
Last Updated
July 23, 2021