RecruitingPhase 1NCT07037758

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

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Sponsor

Amgen

Enrollment

380 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Extensive-stage Small-cell Lung Cancer

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of tarlatamab (a targeted immune therapy) and AB248 (an experimental drug) in patients with extensive-stage small cell lung cancer (ES-SCLC) — an aggressive form of lung cancer that has spread beyond the chest. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with extensive-stage small cell lung cancer confirmed by biopsy - You have received prior chemotherapy for this cancer - Your overall health allows you to participate (measured by performance status) **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have serious autoimmune conditions - You have had prior treatment with a bispecific T-cell engager (like tarlatamab) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTarlatamab

Administered as an IV infusion.

DRUGAB248

Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Locations(19)

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

Memorial Sloan Kettering Cancer Center

Boston, Massachusetts, United States

Siteman Cancer Center

St Louis, Missouri, 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)

View Full Details on ClinicalTrials.gov

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NCT07037758

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