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Trial Title:
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
NCT ID:
NCT06598306
Condition:
Extensive Stage Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
AMG 757
Conditions: Keywords:
Small Cell Lung Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tarlatamab
Description:
Administered by SC injection.
Arm group label:
Part 1 Dose Exploration
Arm group label:
Part 2 Dose Expansion
Other name:
AMG 757
Other name:
Imdelltra
Summary:
The primary objective of this study is to evaluate the safety and tolerability of
subcutaneous (SC) tarlatamab.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 regimen.
- 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 (and/or
thigh).
- Participants without measurable disease or tumor tissue (fresh biopsy or archival)
available may be permitted after discussion with and approval by Amgen Medical
Monitor.
Exclusion Criteria:
- Participants that have received prior DLL3 targeted therapy.
- Participants with untreated or symptomatic brain metastases or those requiring
therapy with steroids.
- Note: Participants with asymptomatic brain metastatic lesions are allowed following
definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic
brain metastasis if local therapy is not required per investigator judgment).
- Participants with leptomeningeal disease.
- Participants with baseline oxygen requirement.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California, Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Recruiting
Facility:
Name:
Calvary Mater Newcastle Hospital
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Recruiting
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
Status:
Recruiting
Start date:
October 7, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06598306
http://www.amgentrials.com
