Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
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)
Sponsor: Amgen + BeOne Medicines
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants with Dose-limiting toxicities (DLTs)
Time frame: Up to day 21
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 24 months
Number of Participants with Changes in Vital Signs
Time frame: Up to approximately 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame: Up to approximately 24 months
Secondary Endpoints
Maximum Serum Concentration (Cmax) of Tarlatamab
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
Time to Cmax (Tmax) of Tarlatamab
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 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 untreate…
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