Clinical trial NCT06598306: Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Extensive Stage Small Cell Lung Cancer
Keywords: Small Cell Lung Cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Dose-limiting toxicities (DLTs)
timeFrame: Up to day 21
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 24 months
measure: Number of Participants with Changes in Vital Signs
timeFrame: Up to approximately 24 months
measure: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of Tarlatamab
timeFrame: Up to approximately 12 months
measure: Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab
timeFrame: Up to approximately 12 months
measure: Time to Cmax (Tmax) of Tarlatamab
timeFrame: Up to approximately 12 months
measure: Area Under the Concentration-time Curve (AUC) of Tarlatamab
timeFrame: Up to approximately 12 months
measure: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
timeFrame: Up to approximately 24 months
measure: Duration of Response (DOR) per RECIST 1.1
timeFrame: Up to approximately 24 months
measure: Time to Response (TTR) per RECIST 1.1
timeFrame: Up to approximately 24 months
measure: Progression-free Survival (PFS) per RECIST 1.1
timeFrame: Up to approximately 24 months
measure: Time to Progression per RECIST 1.1
timeFrame: Up to approximately 24 months
measure: Time to Subsequent Therapy
timeFrame: Up to approximately 24 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 24 months
measure: Number of Participants with Anti-tarlatamab Antibody Formation
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California, Norris Comprehensive Cancer Center
state: California
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: Trinity Health Saint Joseph Mercy Ann Arbor
state: Michigan
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Adana
country: Turkey
facility: Adana Sehir Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Koc Universitesi Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: