RecruitingRecruiting
A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
NCT07037758 · Amgen
In plain English
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Official title
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)
About this study
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 criteria
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 design
Enrollment target: 380 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-16
Estimated completion: 2031-01-18
Last updated: 2026-05-29
Interventions
Drug: TarlatamabDrug: AB248
Primary outcomes
- • Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Up to 2.5 years)
- • Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs) (Up to 35 days)
Sponsor
Amgen · industry
With: Asher Biotherapeutics, Inc.
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (19)
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
University of Southern California, Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Emory UniversityRecruiting
Atlanta, Georgia, United States
Norton Cancer Institute - DowntownRecruiting
Louisville, Kentucky, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Sidney Kimmel Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Allegheny General HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Avera Cancer InstituteRecruiting
Sioux Falls, South Dakota, United States
Baptist Cancer CenterRecruiting
Memphis, Tennessee, United States
Swedish Cancer Institute Medical OncologyRecruiting
Seattle, Washington, United States
Chungbuk National University HospitalRecruiting
Cheongju Chungbuk, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Adana Sehir Egitim ve Arastirma HastanesiRecruiting
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi HastanesiRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)