Trial Title:
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
NCT ID:
NCT03319940
Condition:
Small Cell Lung Carcinoma
Conditions: Official terms:
Small Cell Lung Carcinoma
Pembrolizumab
Conditions: Keywords:
Half-Life Extended (HLE) Bispecific T cell engager (BiTE®)
Delta-like protein 3 (DLL3)
Tarlatamab
Oncology
Immunology
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab
monotherapy, in combination with anti-PD1 therapy and with additional CRS mitigation
strategies in participants with SCLC. The dose exploration phases of the study will
estimate the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D) of
tarlatamab either as monotherapy or in combination with pembrolizumab. This will be
followed by dose expansion phase to confirm RP2D and to obtain further safety and
efficacy data.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
The patient, investigator, investigative staff, medical monitor and care provider will
not be masked for the study.
Intervention:
Intervention type:
Drug
Intervention name:
Tarlatamab
Description:
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting
delta-like protein 3 (DLL3)
Arm group label:
Part A
Arm group label:
Part C
Arm group label:
Part D
Arm group label:
Part E
Arm group label:
Part F
Arm group label:
Part G
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity
of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
Arm group label:
Part C
Intervention type:
Drug
Intervention name:
CRS Mitigation Strategies
Description:
Participants will be treated with one of the CRS mitigation strategies.
Arm group label:
Part D
Summary:
A study to assess the safety, tolerability, and PK of tarlatamab in participants with
SCLC
Detailed description:
This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab
monotherapy, in combination with anti-PD1 therapy and with additional cytokine release
syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term
intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended
(HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant has provided informed consent prior to initiation of any study-specific
activities/procedures
- Age greater than or equal to 18 years old at the time of signing the informed
consent
- Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G:
relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred
following platinum-based regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Participants with treated brain metastases are eligible provided they meet defined
criteria
- Adequate organ function as defined in protocol
Exclusion Criteria:
- History of other malignancy within the past 2 years prior to first dose of
tarlatamab with exceptions
- Major surgery within 28 days of first dose tarlatamab
- Untreated (includes new lesions or progression in previously treated lesions) or
symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic
or not).
- Prior anti-cancer therapy: at least 28 days must have elapsed between any prior
anti-cancer therapy and first dose of tarlatamab with the following exceptions:
participants who received conventional chemotherapy are eligible if at least 14 days
have elapsed and if all treatment-related toxicity has been resolved to Grade less
than or equal to 1; and prior palliative radiotherapy must have been completed at
least 7 days before the first dose of tarlatamab
- Participants who experienced severe, life-threatening or recurrent (Grade 2 or
higher) immune-mediated AEs or infusion-related reactions including those that lead
to permanent discontinuation while on treatment with immune-oncology agents
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of
tarlatamab
- Part C only: history of solid organ transplantation or active autoimmune disease
that has required systemic treatment within the past 2 years
- Participant with symptoms and/or clinical signs and/or radiographic signs that
indicate an acute and/or uncontrolled active systemic infection within 7 days prior
to the first dose of investigational product administration
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope National Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Yale New Haven Hospital
Address:
City:
New Haven
Zip:
06510
Country:
United States
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Facility:
Name:
University of Chicago
Address:
City:
Chicago
Zip:
60637
Country:
United States
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Facility:
Name:
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Facility:
Name:
Henry Ford Health System
Address:
City:
Detroit
Zip:
48202
Country:
United States
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110-1093
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10021
Country:
United States
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Facility:
Name:
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Facility:
Name:
University of Pittsburgh Medical Center Cancer Pavillion
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
Chris OBrien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Facility:
Name:
Medizinische Universitaet Graz
Address:
City:
Graz
Zip:
8036
Country:
Austria
Facility:
Name:
Landeskrankenhaus Salzburg
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Facility:
Name:
Universitaetsklinikum Wuerzburg
Address:
City:
Wuerzburg
Zip:
97078
Country:
Germany
Facility:
Name:
Prince of Wales Hospital
Address:
City:
Shatin, New Territories
Country:
Hong Kong
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
Facility:
Name:
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Facility:
Name:
Maastricht Universitair Medisch Centrum
Address:
City:
Maastricht
Zip:
6229 HX
Country:
Netherlands
Facility:
Name:
Biokinetica SA
Address:
City:
Jozefow
Zip:
05-410
Country:
Poland
Facility:
Name:
Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina
Address:
City:
Otwock
Zip:
05-400
Country:
Poland
Facility:
Name:
Hospital Universitari Vall d Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Hospital Clinic i Provincial de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Facility:
Name:
Centre Hospitalier Universitaire Vaudois
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Facility:
Name:
Kantonsspital St Gallen
Address:
City:
Sankt Gallen
Zip:
9007
Country:
Switzerland
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Facility:
Name:
Tri-Service General Hospital
Address:
City:
Taipei
Zip:
11490
Country:
Taiwan
Facility:
Name:
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Address:
City:
Taoyuan
Zip:
33305
Country:
Taiwan
Facility:
Name:
Christie Hospital
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Start date:
December 26, 2017
Completion date:
October 18, 2025
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT03319940
http://www.amgentrials.com
