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

NCT06598306 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 20230298
• Study Type: interventional
• Target: 220
• Locations: 10 countries
• Sites: 30

Brief Summary

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

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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

Study Arms (3)

Part 1 Dose Exploration

EXPERIMENTAL

Tarlatamab will be administered as a SC injection in Part 1.

Drug: Tarlatamab

Part 2 Dose Expansion

EXPERIMENTAL

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

Part 3 Alternative Dosing

EXPERIMENTAL

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

Interventions

Tarlatamab DRUG

Administered by SC injection.

Also known as: AMG 757, Imdelltra

Part 1 Dose Exploration; Part 2 Dose Expansion; Part 3 Alternative Dosing

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead
• BeOne Medicines: collaborator

Study Sites (30)

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan, 48106, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

RECRUITING

Chris OBrien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Calvary Mater Newcastle Hospital

Waratah, New South Wales, 2298, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 4000, Belgium

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Universitaetsklinikum Regensburg

Regensburg, 93053, Germany

RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany

RECRUITING

Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

RECRUITING

Wakayama Medical University Hospital

Wakayama, 641-8509, Japan

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338, Poland

RECRUITING

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, 37-700, Poland

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, Andalusia, 29011, Spain

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Kantonsspital Graubuenden

Chur, 7000, Switzerland

RECRUITING

Freiburg Spital

Fribourg, 1708, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

RECRUITING

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01370, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Koc Universitesi Hastanesi

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

AMG 757

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 27, 2030
• Last Updated: December 1, 2025

Record last verified: 2025-11

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

AU (3); ES (4); TU (3); DE (2); US (6); CH (3); JP (2); PL (3); BE (3); CN (1)