Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmgen
About this trial
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Tarlatamab
DrugAdministered by SC injection.
Treatment groups
220 Participants
are divided into 3 treatment groupsGroup A: Part 1 Dose ExplorationExperimental treatment 1 intervention
Group B: Part 2 Dose ExpansionExperimental treatment 1 intervention
Group C: Part 3 Alternative DosingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Dose-limiting toxicities (DLTs)
Time frame
Up to day 212
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame
Up to approximately 24 months3
Number of Participants with Changes in Vital Signs
Time frame
Up to approximately 24 months4
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time frame
Up to approximately 24 monthsSecondary outcomes
1
Maximum Serum Concentration (Cmax) of Tarlatamab
Time frame
Up to approximately 12 months2
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
Time frame
Up to approximately 12 months3
Time to Cmax (Tmax) of Tarlatamab
Time frame
Up to approximately 12 months4
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Time frame
Up to approximately 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Amgen
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov