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Recruiting Phase 1

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

NCT07037758 · tracked via the Priya Life Science Turkey tracker
Sponsor
Phase
Phase 1
Started
2025-09-16
Last updated
2026-09-25

Condition(s) studied

Extensive Stage Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Tarlatamab →AB248 →

Tarlatamab: Administered as an IV infusion.

AB248: Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Study 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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy 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.

Primary outcome measure(s)

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) — Up to 2.5 years
    Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.
  • Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs) — Up to 35 days

Trial sites (19)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07037758 on ClinicalTrials.gov ↗ ← All trials in Turkey