NCT07037758RecruitingPhase 1
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)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 17 Jun 2025
- Start date
- 16 Sept 2025
- Primary completion date
- 18 Mar 2028
- Lead sponsor
- Amgen
- Diseases
- Lung cancer
- NCT number
- NCT07037758
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 380
- From 16 Sept 2025 to the primary completion date, 18 Mar 2028
- 19 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
- Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
Other
- Symptomatic central nervous system (CNS) metastases.
- Participants with brain metastases may be eligible if criteria defined in the protocol are met.
- Baseline (at rest) requirement of supplemental oxygen.
Who the study is looking for
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- 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.
- Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
- Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju Chungbuk | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si, Gyeonggi-do | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Terminated |
| University of Southern California Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Norton Cancer Institute, Downtown Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Baptist Cancer Center Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Swedish Cancer Institute Medical Oncology Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Avera Cancer Institute Coordinator of this site? Confirm its status | Sioux Falls | United States | Recruiting |
| Siteman Cancer Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Adana Sehir Egitim ve Arastirma Hastanesi Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Hacettepe Universitesi Tip Fakultesi Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ankara Bilkent Sehir Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.