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JOURNAL ONKOLOGIE – STUDIE

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Rekrutierend

NCT-Nummer:
NCT03319940

Studienbeginn:
Dezember 2017

Letztes Update:
11.04.2024

Wirkstoff:
Tarlatamab, Pembrolizumab, CRS Mitigation Strategies

Indikation (Clinical Trials):
Small Cell Lung Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 39)

Universitaetsklinikum Wuerzburg
97078 Wuerzburg
(Bayern)
GermanyRekrutierend» Google-Maps
City of Hope National Medical Center
91010 Duarte
United StatesAbgeschlossen» Google-Maps
Yale New Haven Hospital
06510 New Haven
United StatesRekrutierend» Google-Maps
Winship Cancer Institute
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ochsner Clinic Foundation
70121 New Orleans
United StatesRekrutierend» Google-Maps
John Hopkins Sidney Kimmel Comprehensive Cancer Center
21287 Baltimore
United StatesRekrutierend» Google-Maps
Henry Ford Health System
48202 Detroit
United StatesRekrutierend» Google-Maps
Washington University
63110-1093 Saint Louis
United StatesRekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10021 New York
United StatesRekrutierend» Google-Maps
University Hospitals Cleveland Medical Center
44106 Cleveland
United StatesRekrutierend» Google-Maps
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
43210 Columbus
United StatesRekrutierend» Google-Maps
Fox Chase Cancer Center
19111 Philadelphia
United StatesRekrutierend» Google-Maps
University of Pittsburgh Medical Center Cancer Pavillion
15232 Pittsburgh
United StatesAbgebrochen» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesRekrutierend» Google-Maps
Prince of Wales Hospital
Shatin, New Territories
Hong KongRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
Wakayama Medical University Hospital
641-8510 Wakayama-shi
JapanRekrutierend» Google-Maps
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
1066 CX Amsterdam
NetherlandsRekrutierend» Google-Maps
Maastricht Universitair Medisch Centrum
6229 HX Maastricht
NetherlandsAbgeschlossen» Google-Maps
Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina
05-400 Otwock
PolandRekrutierend» Google-Maps
Hospital Universitari Vall d Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Clinic i Provincial de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Centre Hospitalier Universitaire Vaudois
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Kantonsspital St Gallen
9007 Sankt Gallen
SwitzerlandRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
80756 Kaohsiung
TaiwanRekrutierend» Google-Maps
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
33305 Taoyuan
TaiwanRekrutierend» Google-Maps
Christie Hospital
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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)

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Number of participants with dose limiting toxicities (DLT) for all indications (Time Frame - 6 months)

2. Number of participants with treatment-emergent adverse events (AEs) for all indications (Time Frame - 4 years)

3. Number of participants with treatment-related AEs for all indications (Time Frame - 4 years)

4. Number of participants with clinically significant changes in vital signs for all indications (Time Frame - 4 years)

5. Number of participants with significant changes in electrocardiogram (ECG) for all indications (Time Frame - 4 years)

6. Number of participants with significant changes in physical examinations for all indications (Time Frame - 4 years)

7. Number of participants with significant changes in clinical laboratory tests for all indications (Time Frame - 4 years)

Secondary outcome:

1. Maximum observed concentration (Cmax) following intravenous administration for all indications (Time Frame - 4 years)

2. Minimum observed concentration (Cmin) following intravenous administration for all indications (Time Frame - 4 years)

3. Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications (Time Frame - 4 years)

4. Accumulation following multiple dosing for all indications (Time Frame - 4 years)

5. Half-life (t1/2) following intravenous administration for all indications (Time Frame - 4 years)

6. Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Time Frame - 4 years):
Only for parts A, D, E, F, and G

7. Duration of Response (DOR) for all indications (Time Frame - 4 years)

8. Time to Response (TTR) (Time Frame - 4 years)

9. 9-month Progression-Free Survival (PFS) for all indications (Time Frame - 9 months)

10. 9-month Overall Survival (OS) for all indications (Time Frame - 9 months)

Studien-Arme

  • Experimental: Part A
    Tarlatamab monotherapy
  • Experimental: Part C
    Tarlatamab with Pembrolizumab
  • Experimental: Part D
    Tarlatamab with additional CRS mitigation strategies
  • Experimental: Part E
    Tarlatamab administration with 24-hour monitoring
  • Experimental: Part F
    Tarlatamab administered in outpatient infusion centers with 8-hour monitoring Optional wearable digital device substudy (US sites only)
  • Experimental: Part G
    Tarlatamab additional dosing schedule Optional wearable digital device substudy (US sites only)

Geprüfte Regime

  • Tarlatamab:
    Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
  • Pembrolizumab:
    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
  • CRS Mitigation Strategies:
    Participants will be treated with one of the CRS mitigation strategies.

Quelle: ClinicalTrials.gov


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