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

NCT07037758 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20240200
• Study Type: interventional
• Target: 380
• Locations: 3 countries
• Sites: 19

Brief 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.

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

ES-SCLC; Tarlatamab; AMG 757; AB248; Imdelltra

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.

  Up to 2.5 years

• Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)

  Up to 35 days

Secondary Outcomes (13)

• Maximum Serum Concentration (Cmax) of Tarlatamab

  Up to approximately 21 weeks

• Minimum Serum Concentration (Cmin) of Tarlatamab

  Up to approximately 21 weeks

• Area Under the Concentration-time Curve (AUC) of Tarlatamab

  Up to approximately 21 weeks

• Half-life (t1/2) of Tarlatamab

  Up to approximately 21 weeks

• Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Up to 2.5 years

Study Arms (2)

Dose Exploration

EXPERIMENTAL

Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion.

Drug: Tarlatamab; Drug: AB248

Dose Expansion

EXPERIMENTAL

The dose expansion part will test tarlatamab in combination with the MTCD/recommended dose for expansion of AB248 identified in the dose exploration part. An optional cohort may be opened based on emerging data to study tarlatamab in combination with AB248 at a lower dose than the MTCD/recommended dose for expansion or with an alternative dose regimen at a AB248 dose lower than or equal to MTCD/recommended dose for expansion.

Drug: Tarlatamab; Drug: AB248

Interventions

AB248 DRUG

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

Dose Expansion; Dose Exploration

Tarlatamab DRUG

Administered as an IV infusion.

Also known as: AMG 757, Imdelltra

Dose Expansion; Dose Exploration

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead
• Asher Biotherapeutics, Inc.: collaborator

Study Sites (19)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Norton Cancer Institute - Downtown

Louisville, Kentucky, 40202-1703, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

Boston, Massachusetts, 02215, United States

RECRUITING

Siteman Cancer Center

St Louis, Missouri, 63110, United States

RECRUITING

Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

RECRUITING

Swedish Cancer Institute Medical Oncology

Seattle, Washington, 98109, United States

RECRUITING

Chungbuk National University Hospital

Cheongju Chungbuk, 28644, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01370, Turkey (Türkiye)

RECRUITING

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

AMG 757

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): March 18, 2028
• Study Completion (Estimated): January 18, 2031
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (13); KR (3); TU (3)