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NCT07037758PHASE1Recruiting

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

Amgen

Start Date

9/16/2025

Completion Date

1/18/2031

Summary

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

Age Range: 18 years to 90 years

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.

Interventions

DRUG

Tarlatamab

DRUG

AB248

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Conditions

Extensive Stage Small Cell Lung Cancer

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Emory University

Atlanta, Georgia 30322

United States

Norton Cancer Institute - Downtown

Louisville, Kentucky 40202-1703

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Siteman Cancer Center

St Louis, Missouri 63110

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania 19107

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Baptist Cancer Center

Memphis, Tennessee 38120

United States

Swedish Cancer Institute Medical Oncology

Seattle, Washington 98109

United States

Chungbuk National University Hospital

Cheongju Chungbuk, 28644

South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620

South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722

South Korea

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01370

Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06230

Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, 06800

Turkey (Türkiye)