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Recruiting
Sponsor ID
20230298

Subcutaneous Tarlatamab in Participants with Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Sponsor ID
20230298
Clinicaltrials.gov ID
NCT06598306
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Additional Study Details

Phase
Phase 1
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
220
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Dose-limiting toxicities (DLTs)

Timeframe: Up to day 21

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 24 months

Number of Participants with Changes in Vital Signs

Timeframe: Up to approximately 24 months

Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

Timeframe: Up to approximately 24 months

Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of Tarlatamab

Timeframe: Up to approximately 12 months

Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab

Timeframe: Up to approximately 12 months

Time to Cmax (Tmax) of Tarlatamab

Timeframe: Up to approximately 12 months

Area Under the Concentration-time Curve (AUC) of Tarlatamab

Timeframe: Up to approximately 12 months

Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Timeframe: Up to approximately 24 months

Duration of Response (DOR) per RECIST 1.1

Timeframe: Up to approximately 24 months

Time to Response (TTR) per RECIST 1.1

Timeframe: Up to approximately 24 months

Progression-free Survival (PFS) per RECIST 1.1

Timeframe: Up to approximately 24 months

Time to Progression per RECIST 1.1

Timeframe: Up to approximately 24 months

Time to Subsequent Therapy

Timeframe: Up to approximately 24 months

Overall Survival (OS)

Timeframe: Up to approximately 24 months

Number of Participants with Anti-tarlatamab Antibody Formation

Timeframe: Up to approximately 24 months

Locations

Location
Status
Contact Us
Location
Calvary Mater Newcastle Hospital
Waratah, NSW, Australia, 2298
Status
Recruiting
Location
Avera Cancer Institute
Sioux Falls, SD, United States, 57105
Status
Recruiting
Location
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, CA, United States, 90033
Status
Recruiting
Location
Wakayama Medical University Hospital
Wakayama-shi, Wakayama, Japan, 641-8510
Status
Recruiting
Location
The Alfred Hospital
Melbourne, VIC, Australia, 3004
Status
Recruiting
Location
Okayama University Hospital
Okayama-shi, Okayama, Japan, 700-8558
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Lung Cancer - Small Cell
    • Sex
    All
    Trial Dates
    Oct 2024 - Apr 2027
    Inclusion and Exclusion 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 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.
    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.