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RecruitingInterventionalPhase 1

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)

NCT ID: NCT07037758Sponsor: AmgenLast updated: 2026-05-29

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.

Arms & 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.

Outcome measures

Primary

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.

    Time frame: Up to 2.5 years

  • Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)

    Time frame: Up to 35 days

Secondary

  • Maximum Serum Concentration (Cmax) of Tarlatamab

    Time frame: Up to approximately 21 weeks

  • Minimum Serum Concentration (Cmin) of Tarlatamab

    Time frame: Up to approximately 21 weeks

  • Area Under the Concentration-time Curve (AUC) of Tarlatamab

    Time frame: Up to approximately 21 weeks

  • Half-life (t1/2) of Tarlatamab

    Time frame: Up to approximately 21 weeks

  • Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time frame: Up to 2.5 years

  • Duration of Response (DOR) per RECIST 1.1

    Time frame: Up to 2.5 years

  • Time to Response (TTR) per RECIST 1.1

    Time frame: Up to 2.5 years

  • Disease Control (DC) per RECIST 1.1

    Time frame: Up to 2.5 years

  • Progression-free Survival (PFS) per RECIST 1.1

    Time frame: Up to 2.5 years

  • Time to Progression (TTP) per RECIST 1.1

    Time frame: Up to 2.5 years

  • Time to Subsequent Therapy

    Time frame: Up to 2.5 years

  • Overall Survival (OS)

    Time frame: Up to 2.5 years

  • Number of Participants with Anti-AB248 Antibody Formation

    Time frame: Up to 2.5 years

Eligibility criteria

Sex: AllAge: 18 Years to 90 YearsHealthy volunteers: No
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.

Study locations (13)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234

Recruiting

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Emory University

Atlanta, Georgia, 30322

Recruiting

Norton Cancer Institute - Downtown

Louisville, Kentucky, 40202-1703

Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

Siteman Cancer Center

St Louis, Missouri, 63110

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Recruiting

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107

Recruiting

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

Recruiting

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Recruiting

Baptist Cancer Center

Memphis, Tennessee, 38120

Recruiting

Swedish Cancer Institute Medical Oncology

Seattle, Washington, 98109

Recruiting