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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2024
  • participants needed
    332
  • sponsor
    Amgen
Updated on 17 November 2021
metastasis
pembrolizumab
brain metastases
cancer chemotherapy
platinum-based chemotherapy
delta-like protein 3

Summary

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

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)

Details
Condition Small Cell Lung Cancer, sclc, small cell carcinoma, small cell carcinoma of the lung
Treatment Pembrolizumab, AMG 757, CRS Mitigation Strategies
Clinical Study IdentifierNCT03319940
SponsorAmgen
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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