A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAmgen
About this trial
The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.
The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.
Eligibility criteria
Qualifiers
Participant has provided informed consent before initiation of any study-specific activities/procedures.
Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
Disqualifiers
Symptomatic central nervous system (CNS) metastases.
Participants with brain metastases may be eligible if criteria defined in the protocol are met.
Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
Trial design
Treatments tested in this trial
- Tarlatamab
- AB248
Treatment groups
380 Participants
are divided into 2 treatment groupsSponsors and collaborators
Amgen
Lead sponsor
Asher Biotherapeutics, Inc.
Collaborator
Source ClinicalTrials.gov