AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Completed · Phase 1
Conditions studied: Small Cell Lung Cancer
In brief
The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.
Key facts
- Study ID
- NCT04885998
- Run by
- Amgen
- People needed
- 23
- Starts
- 2021-09-27
- Expected to finish
- 2024-09-11
- Last updated by the study team
- 2025-09-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- History of other malignancy within the past 2 years with exceptions
- Major surgery within 28 days of first dose of tarlatamab
- 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 tarlatamab
- Exceptions:
- Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab 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 tarlatamab
- Participants who received prior tarlatamab 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 tarlatamab
- 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
Where it is running
- Northwestern University, Robert H Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Kentucky — Lexington, Kentucky, United States
- Wake Forest Baptist Comprehensive Cancer Research Center — Winston-Salem, North Carolina, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Tennessee Oncology, PLLC — Nashville, Tennessee, United States
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
- Medizinische Universitaet Innsbruck — Innsbruck, Austria
- Universitaetsklinikum Allgemeines Krankenhaus Wien — Vienna, Austria
- Universitair Ziekenhuis Antwerpen — Edegem, Belgium
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Belgium
- National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
- National University Hospital — Singapore, Singapore
- National Cancer Centre Singapore — Singapore, Singapore
- Chung Shan Medical University Hospital — Taichung, Taiwan
- Taipei Veterans General Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
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