Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) (DeLLphi-308)

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Study Overview

• Status: Recruiting
• Conditions: Extensive Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: Tarlatamab

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Chris OBrien Lifehouse
    • Waratah, New South Wales, Australia, 2298
      • Recruiting
      • Calvary Mater Newcastle Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • The Alfred Hospital
• Belgium
  • Ghent, Belgium, 9000
    • Recruiting
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitair Ziekenhuis Leuven - Campus Gasthuisberg
  • Liège, Belgium, 4000
    • Recruiting
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
• China
  • Jilin
    • Changchun, Jilin, China, 130012
      • Recruiting
      • Jilin Cancer Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
• Germany
  • Regensburg, Germany, 93053
    • Recruiting
    • Universitaetsklinikum Regensburg
  • Würzburg, Germany, 97078
    • Recruiting
    • Universitaetsklinikum Wuerzburg
• Japan
  • Wakayama, Japan, 641-8509
    • Recruiting
    • Wakayama Medical University Hospital
  • Okayama-ken
    • Okayama, Okayama-ken, Japan, 700-8558
      • Recruiting
      • Okayama University Hospital
• Poland
  • Gdansk, Poland, 80-214
    • Recruiting
    • Uniwersyteckie Centrum Kliniczne
  • Lodz, Poland, 93-338
    • Recruiting
    • Instytut Centrum Zdrowia Matki Polki
  • Przemyśl, Poland, 37-700
    • Recruiting
    • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Andalusia
    • Málaga, Andalusia, Spain, 29011
      • Recruiting
      • Hospital Regional Universitario de Malaga
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Recruiting
      • Hospital Universitari Vall D Hebron
  • Valencia
    • Valencia, Valencia, Spain, 46026
      • Recruiting
      • Hospital Universitari i Politecnic La Fe
• Switzerland
  • Chur, Switzerland, 7000
    • Recruiting
    • Kantonsspital Graubuenden
  • Fribourg, Switzerland, 1708
    • Recruiting
    • Freiburg Spital
  • Winterthur, Switzerland, 8401
    • Recruiting
    • Kantonsspital Winterthur
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01370
    • Recruiting
    • Adana Sehir Egitim ve Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06800
    • Recruiting
    • Ankara Bilkent Sehir Hastanesi
  • Istanbul, Turkey (Türkiye), 34010
    • Recruiting
    • Koç Üniversitesi Hastanesi
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California, Norris Comprehensive Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Chicago
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Recruiting
      • Trinity Health Saint Joseph Mercy Ann Arbor
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Avera Cancer Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Swedish Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
• Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.

Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
• Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
• Participants must be able to have SC injections administered in the abdomen.
• Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.

Exclusion Criteria:

• Participants that have received prior DLL3 targeted therapy.
• Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
• Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
• Participants with leptomeningeal disease.
• Participants with baseline oxygen requirement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Dose Exploration; Tarlatamab will be administered as a SC injection in Part 1.	Drug: Tarlatamab; Administered by SC injection.; Other Names: AMG 757; Imdelltra
Experimental: Part 2 Dose Expansion; Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.	Drug: Tarlatamab; Administered by SC injection.; Other Names: AMG 757; Imdelltra
Experimental: Part 3 Alternative Dosing; Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.	Drug: Tarlatamab; Administered by SC injection.; Other Names: AMG 757; Imdelltra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Dose-limiting toxicities (DLTs)	Up to day 21
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to approximately 24 months
Number of Participants with Changes in Vital Signs	Up to approximately 24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to approximately 24 months
Maximum Serum Concentration (Cmax) of Tarlatamab	Up to approximately 12 months
Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab	Up to approximately 12 months
Time to Cmax (Tmax) of Tarlatamab	Up to approximately 12 months
Area Under the Concentration-time Curve (AUC) of Tarlatamab	Up to approximately 12 months
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1	Up to approximately 24 months
Duration of Response (DOR) per RECIST 1.1	Up to approximately 24 months
Time to Response (TTR) per RECIST 1.1	Up to approximately 24 months
Progression-free Survival (PFS) per RECIST 1.1	Up to approximately 24 months
Time to Progression per RECIST 1.1	Up to approximately 24 months
Time to Subsequent Therapy	Up to approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Amgen
• Collaborators: BeOne Medicines
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): April 24, 2030

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents; AMG 757
• Other Study ID Numbers: 20230298 (Swedish Heart Lung Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No