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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03319940




Registration number
NCT03319940
Ethics application status
Date submitted
5/10/2017
Date registered
24/10/2017
Date last updated
11/04/2024

Titles & IDs
Public title
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
Scientific title
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
Secondary ID [1] 0 0
20160323
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Tarlatamab
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - CRS Mitigation Strategies

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)


Treatment: Drugs: Tarlatamab
Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Treatment: Drugs: 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

Treatment: Drugs: CRS Mitigation Strategies
Participants will be treated with one of the CRS mitigation strategies.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with dose limiting toxicities (DLT) for all indications
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Number of participants with treatment-emergent adverse events (AEs) for all indications
Timepoint [2] 0 0
4 years
Primary outcome [3] 0 0
Number of participants with treatment-related AEs for all indications
Timepoint [3] 0 0
4 years
Primary outcome [4] 0 0
Number of participants with clinically significant changes in vital signs for all indications
Timepoint [4] 0 0
4 years
Primary outcome [5] 0 0
Number of participants with significant changes in electrocardiogram (ECG) for all indications
Timepoint [5] 0 0
4 years
Primary outcome [6] 0 0
Number of participants with significant changes in physical examinations for all indications
Timepoint [6] 0 0
4 years
Primary outcome [7] 0 0
Number of participants with significant changes in clinical laboratory tests for all indications
Timepoint [7] 0 0
4 years
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax) following intravenous administration for all indications
Timepoint [1] 0 0
4 years
Secondary outcome [2] 0 0
Minimum observed concentration (Cmin) following intravenous administration for all indications
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications
Timepoint [3] 0 0
4 years
Secondary outcome [4] 0 0
Accumulation following multiple dosing for all indications
Timepoint [4] 0 0
4 years
Secondary outcome [5] 0 0
Half-life (t1/2) following intravenous administration for all indications
Timepoint [5] 0 0
4 years
Secondary outcome [6] 0 0
Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timepoint [6] 0 0
4 years
Secondary outcome [7] 0 0
Duration of Response (DOR) for all indications
Timepoint [7] 0 0
4 years
Secondary outcome [8] 0 0
Time to Response (TTR)
Timepoint [8] 0 0
4 years
Secondary outcome [9] 0 0
9-month Progression-Free Survival (PFS) for all indications
Timepoint [9] 0 0
9 months
Secondary outcome [10] 0 0
9-month Overall Survival (OS) for all indications
Timepoint [10] 0 0
9 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/10/2025
Actual
Sample size
Target
392
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
Austria
State/province [14] 0 0
Graz
Country [15] 0 0
Austria
State/province [15] 0 0
Salzburg
Country [16] 0 0
France
State/province [16] 0 0
Villejuif
Country [17] 0 0
Germany
State/province [17] 0 0
Wuerzburg
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Shatin, New Territories
Country [19] 0 0
Japan
State/province [19] 0 0
Chiba
Country [20] 0 0
Japan
State/province [20] 0 0
Tokyo
Country [21] 0 0
Japan
State/province [21] 0 0
Wakayama
Country [22] 0 0
Netherlands
State/province [22] 0 0
Amsterdam
Country [23] 0 0
Netherlands
State/province [23] 0 0
Maastricht
Country [24] 0 0
Poland
State/province [24] 0 0
Jozefow
Country [25] 0 0
Poland
State/province [25] 0 0
Otwock
Country [26] 0 0
Spain
State/province [26] 0 0
Cataluña
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Switzerland
State/province [28] 0 0
Lausanne
Country [29] 0 0
Switzerland
State/province [29] 0 0
Sankt Gallen
Country [30] 0 0
Taiwan
State/province [30] 0 0
Kaohsiung
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taipei
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taoyuan
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
Trial website
https://clinicaltrials.gov/ct2/show/NCT03319940
Trial related presentations / publications
Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2.
Paz-Ares L, Champiat S, Lai WV, Izumi H, Govindan R, Boyer M, Hummel HD, Borghaei H, Johnson ML, Steeghs N, Blackhall F, Dowlati A, Reguart N, Yoshida T, He K, Gadgeel SM, Felip E, Zhang Y, Pati A, Minocha M, Mukherjee S, Goldrick A, Nagorsen D, Hashemi Sadraei N, Owonikoko TK. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. J Clin Oncol. 2023 Jun 1;41(16):2893-2903. doi: 10.1200/JCO.22.02823. Epub 2023 Jan 23.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03319940