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

• Status: Recruiting
• Trial end date: 2024-08-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Pembrolizumab

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