AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

• Status: Recruiting
• Trial end date: 2025-03-25
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of AMG 757 in combination with AMG 404.

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

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

• Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures

• Age greater than or equal to 18 years old at the same time of signing the informed consent

• Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen

• Eastern Cooperative Oncology Group (ECOG) 0 to 1

• Participants 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 with exceptions

• Major surgery within 28 days of first dose of AMG 757

• Untreated or symptomatic brain metastases and leptomeningeal disease

• Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti- cancer therapy and the first planned dose of AMG 757

Exceptions:

• Participants who received prior chemotherapy must have completed at least 14 days before the first dose of AMG 757 and all treatment-related toxicity resolved to grade ≤ 1.

• Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of AMG 757

• Participants who received prior AMG 757 therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible

• Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents

• History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis

• Participants with 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

• History of solid organ transplantation

• History of hypophysitis or pituitary dysfunction

• Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted