A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
• Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.
⁃ Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
• Participants must be able to have SC injections administered in the abdomen.
• Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.
Locations
United States
California
University of Southern California, Norris Comprehensive Cancer Center
Centre Hospitalier Universitaire de Liege - Sart Tilman
RECRUITING
Liège
China
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Germany
Universitaetsklinikum Regensburg
RECRUITING
Regensburg
Universitaetsklinikum Wuerzburg
RECRUITING
Würzburg
Japan
Okayama University Hospital
RECRUITING
Okayama
Wakayama Medical University Hospital
RECRUITING
Wakayama
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Instytut Centrum Zdrowia Matki Polki
RECRUITING
Lodz
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
RECRUITING
Przemyśl
Spain
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Switzerland
Kantonsspital Graubuenden
RECRUITING
Chur
Freiburg Spital
RECRUITING
Fribourg
Kantonsspital Winterthur
RECRUITING
Winterthur
Turkey
Adana Sehir Egitim ve Arastirma Hastanesi
RECRUITING
Adana
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Koc Universitesi Hastanesi
RECRUITING
Istanbul
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date:2024-10-07
Estimated Completion Date:2030-03-27
Participants
Target number of participants:220
Treatments
Experimental: Part 1 Dose Exploration
Tarlatamab will be administered as a SC injection in Part 1.
Experimental: Part 2 Dose Expansion
Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.
Experimental: Part 3 Alternative Dosing
Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.