A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
Recruiting · NCT07037758 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
AB248Tarlatamab
What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Symptomatic central nervous system (CNS) metastases.
- Participants with brain metastases may be eligible if criteria defined in the protocol are met.
- Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
- Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
- Baseline (at rest) requirement of supplemental oxygen.
Where it is running
19 locations listed across 12 US states.
- 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
- Siteman Cancer Center - St Louis, Missouri, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, 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
- Adana Sehir Egitim ve Arastirma Hastanesi - Adana, Turkey (Türkiye)
- Hacettepe Universitesi Tip Fakultesi Hastanesi - Ankara, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi - Ankara, Turkey (Türkiye)
- 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