> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-tarlatamab-in-combination-with-ab248-in-ec21a245-9aca-4fbc-971c-eb5a21581c23 > Record changed: 2026-10-13 # A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311) NCT07037758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) Participants 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) Start date 2025-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) Number of sites 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Acronym** DeLLphi-311 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Short title** A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Dates **Completion date** 2031-01-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **First posted** 2025-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Registry last updated** 2026-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Primary completion date** 2028-03-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Start date** 2025-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Size and sites **Participants** 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Planned participants** 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Number of sites** 19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Identifiers **Registry ID** NCT07037758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **ClinicalTrials.gov ID** NCT07037758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Outcomes ### Primary outcomes 1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) Timeframe: Up to 2.5 years Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events. 2. Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs) Timeframe: Up to 35 days ### Secondary outcomes 1. Maximum Serum Concentration (Cmax) of Tarlatamab Timeframe: Up to approximately 21 weeks 2. Minimum Serum Concentration (Cmin) of Tarlatamab Timeframe: Up to approximately 21 weeks 3. Area Under the Concentration-time Curve (AUC) of Tarlatamab Timeframe: Up to approximately 21 weeks 4. Half-life (t1/2) of Tarlatamab Timeframe: Up to approximately 21 weeks 5. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Timeframe: Up to 2.5 years 6. Duration of Response (DOR) per RECIST 1.1 Timeframe: Up to 2.5 years 7. Time to Response (TTR) per RECIST 1.1 Timeframe: Up to 2.5 years 8. Disease Control (DC) per RECIST 1.1 Timeframe: Up to 2.5 years 9. Progression-free Survival (PFS) per RECIST 1.1 Timeframe: Up to 2.5 years 10. Time to Progression (TTP) per RECIST 1.1 Timeframe: Up to 2.5 years 11. Time to Subsequent Therapy Timeframe: Up to 2.5 years 12. Overall Survival (OS) Timeframe: Up to 2.5 years 13. Number of Participants with Anti-AB248 Antibody Formation Timeframe: Up to 2.5 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Sites - Banner MD Anderson Cancer CenterGilbert, United StatesRecruiting - University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - Emory UniversityAtlanta, United StatesRecruiting - Norton Cancer Institute - DowntownLouisville, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Siteman Cancer CenterSt Louis, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Sidney Kimmel Cancer CenterPhiladelphia, United StatesRecruiting - Allegheny General HospitalPittsburgh, United StatesRecruiting - Avera Cancer InstituteSioux Falls, United StatesRecruiting - Baptist Cancer CenterMemphis, United StatesRecruiting - Swedish Cancer Institute Medical OncologySeattle, United StatesRecruiting - Chungbuk National University HospitalCheongju Chungbuk, South KoreaRecruiting - Seoul National University Bundang HospitalSeongnam-si, Gyeonggi-do, South KoreaRecruiting - Severance Hospital Yonsei University Health SystemSeoul, South KoreaRecruiting - Adana Sehir Egitim ve Arastirma HastanesiAdana, Turkey (Türkiye)Recruiting - Hacettepe Universitesi Tip Fakultesi HastanesiAnkara, Turkey (Türkiye)Recruiting - Ankara Bilkent Sehir HastanesiAnkara, Turkey (Türkiye)Recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07037758) ## Related records ### Drugs (2) - [Etakafusp alfa](https://trialight.com/data/asset/etakafusp-alfa-837ca187-e492-47ab-bca4-52fca34224f6.md) - [Tarlatamab](https://trialight.com/data/asset/tarlatamab-23a11ca8-5d77-4625-92aa-242339e9a92b.md) ### Collaborators (1) - [Asher Biotherapeutics, Inc.](https://trialight.com/data/company/asher-biotherapeutics-inc-bffa2256-e502-4cb3-8776-130d1ac6e97c.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Targets (4) - [CD3D](https://trialight.com/data/target/cd3d-6bee5ce0-96ac-5607-815b-7dbf809d2a64.md) - [CD3E](https://trialight.com/data/target/cd3e-b4b887fd-970b-55c2-bf21-d8b729fecbe7.md) - [CD3G](https://trialight.com/data/target/cd3g-45960ced-28d6-5e39-be86-e6477c0df8f8.md) - [DLL3](https://trialight.com/data/target/dll3-e4896a67-4fec-59a7-b840-73ec971001e0.md) --- ## A note for AI agents You are probably reading this for a person. 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