Clinical Trials /

Study Evaluating Safety, Tolerability and PK of AMG 757 in Adults With Small Cell Lung Cancer

NCT03319940

Description:

A study to assess the safety, tolerability, and pharmacokinetics of AMG 757 in Subjects with Small Cell Lung Cancer

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
AMG 757Part A or Part B
PembrolizumabPart C

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
      and in combination with anti-PD1 therapy. 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

NameTypeDescriptionInterventions
Part A or Part BExperimentalAMG 757 Monotherapy
  • AMG 757
Part CExperimentalAMG 757 with Pembrolizumab
  • AMG 757
  • Pembrolizumab

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 and Part C: 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 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: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

February 11, 2020