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

Phase 1

Recruiting

• Conditions: Extensive Stage Small Cell Lung Cancer
• Interventions: Drug: Tarlatamab

• Registration Number: NCT06598306
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Study Start: 2024-10-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-02-01
• Study Completion: 2030-03-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 (and/or thigh).
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1 Dose Exploration	Tarlatamab	Tarlatamab will be administered as a SC injection in Part 1.
Part 2 Dose Expansion	Tarlatamab	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Overall Survival (OS)	Up to approximately 24 months
Number of Participants with Anti-tarlatamab Antibody Formation	Up to approximately 24 months

Trial Locations

Locations (28)

University of Southern California, Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States

Trinity Health Saint Joseph Mercy Ann Arbor; 🇺🇸 Ann Arbor, Michigan, United States

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Swedish Cancer Institute; 🇺🇸 Seattle, Washington, United States

Chris OBrien Lifehouse; 🇦🇺 Camperdown, New South Wales, Australia

Calvary Mater Newcastle Hospital; 🇦🇺 Waratah, New South Wales, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman; 🇧🇪 Liege, Belgium

Universitaetsklinikum Regensburg; 🇩🇪 Regensburg, Germany

Universitaetsklinikum Wuerzburg; 🇩🇪 Wuerzburg, Germany

Okayama University Hospital; 🇯🇵 Okayama-shi, Okayama, Japan

Wakayama Medical University Hospital; 🇯🇵 Wakayama, Japan

Uniwersyteckie Centrum Kliniczne; 🇵🇱 Gdansk, Poland

Instytut Centrum Zdrowia Matki Polki; 🇵🇱 Lodz, Poland

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu; 🇵🇱 Przemysl, Poland

Hospital Regional Universitario de Malaga; 🇪🇸 Malaga, Andalucía, Spain

Hospital Universitari Vall d Hebron; 🇪🇸 Barcelona, Cataluña, Spain

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Kantonsspital Graubuenden; 🇨🇭 Chur, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland

Adana Sehir Egitim ve Arastirma Hastanesi; 🇹🇷 Adana, Turkey

Ankara Bilkent Sehir Hastanesi; 🇹🇷 Ankara, Turkey

Koc Universitesi Hastanesi; 🇹🇷 Istanbul, Turkey