RECRUITING Phase 1 ClinicalTrials.gov

A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Sponsor: Amgen • ClinicalTrials.gov ID: NCT07037758

Registry updated: 2026-09-25

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Description

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.

Interventions

Tarlatamab (Drug)
Administered as an IV infusion.
AB248 (Drug)
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Eligibility criteria

Inclusion Criteria: 1. Participant has provided informed consent before initiation of any study-specific activities/procedures. 2. Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. 3. 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. 4. Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated. 5. Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver). 6. Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy. Exclusion Criteria: 1. Symptomatic central nervous system (CNS) metastases. 2. Participants with brain metastases may be eligible if criteria defined in the protocol are met. 3. Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab). 4. Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy. 5. Baseline (at rest) requirement of supplemental oxygen.

Conditions

Extensive Stage Small Cell Lung Cancer

Locations

Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
University of Southern California, Norris Comprehensive Cancer Center — Los Angeles, California, United States
Moffitt Cancer Center — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
Norton Cancer Institute - Downtown — Louisville, Kentucky, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Siteman Cancer Center — St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States
Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
Avera Cancer Institute — Sioux Falls, South Dakota, United States
Baptist Cancer Center — Memphis, Tennessee, United States
Swedish Cancer Institute Medical Oncology — Seattle, Washington, United States
Chungbuk National University Hospital — Cheongju Chungbuk, South Korea
Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health System — Seoul, South Korea
Adana Sehir Egitim ve Arastirma Hastanesi — Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi — Ankara, Turkey (Türkiye)

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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