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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03319940
Ethics application status
Date submitted
5/10/2017
Date registered
19/10/2017
Date last updated
12/12/2018

Titles & IDs
Public title
Study Evaluating Safety, Tolerability and PK of AMG 757 in Adults With Small Cell Lung Cancer
Scientific title
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer
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
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 757

Experimental: AMG 757 Treatment -


Treatment: Drugs: AMG 757
AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject incidence of dose limiting toxicity - Number of subjects who experience dose limiting toxicities
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Subject incidence of treatment-emergent and treatment-related adverse events - Number of subjects who experience treatment-emergent and treatment-related adverse events
Timepoint [2] 0 0
3 years

Eligibility
Key inclusion criteria
- Age 18 years old at the time of signing the informed consent

- Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC):

- Part A: RR SCLC who progressed or recurred following platinum-based chemotherapy;
Note: Subjects with a diagnosis of combined small cell carcinoma with >50% small
cells may be considered for inclusion in the dose escalation phase of part A
based on investigator discretion and after discussion with the medical monitor

- Part B: ED SCLC with ongoing clinical benefit (stable disease [SD], partial
response [PR], or complete response [CR]) following no more than 6 cycles of
first-line platinum-based chemotherapy with the last dose of chemotherapy greater
then equal to 28 days prior to the study day 1 (first-line consolidation setting)

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Minimum life expectancy of 12 weeks

- Indication A only: at least 2 measurable lesions as defined per modified RECIST 1.1
within 28 days prior to the first dose of AMG 757

- Subjects with treated brain metastases are eligible provided they meet the following
criteria:

- Definitive therapy was completed at least 2 weeks prior to the first dose of AMG
757.

- There is no evidence of radiographic CNS progression or CNS disease following
definitive therapy and by the time of study screening. Patients manifesting
progression in lesions previously treated with stereotactic radiosurgery may
still be eligible if pseudo progression can be demonstrated by appropriate means
and after discussion with the medical monitor.

- Any CNS disease is asymptomatic, any neurologic symptoms due to CNS disease have
returned to baseline or are deemed irreversible, the patient is off steroids for
at least 7 days (physiologic doses of steroids are permitted), and the patient is
off or on stable doses of anti-epileptic drugs for malignant CNS disease.
Minimum age
18 Years
Maximum age
No limit
Gender
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 AMG 757
except:

- Malignancy (other than in situ) treated with curative intent and with no known
active disease present for 2 years before first dose of AMG 757 and felt to be at
low risk for recurrence by the treating physician.

- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.

- Adequately treated in situ cancer without evidence of disease.

- Prostatic intraepithelial neoplasia without evidence of prostate cancer

- Adequately treated urothelial papillary noninvasive carcinoma

- Major surgery within 28 days of first dose AMG 757

- Untreated or symptomatic brain metastases and leptomeningeal disease

- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart
Association > class II) within 12 months of first dose of AMG 757

- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12
months of first dose of AMG 757

- Presence of fungal, bacterial, viral, or other infection requiring oral or IV
antimicrobials for management within 7 days of first dose AMG 757

- Prior anti-cancer therapy: at least 28 days must have elapsed between any prior
anti-cancer therapy and first dose of AMG 757

Exceptions:

- Subjects who received conventional chemotherapy are eligible if at least 14 days have
elapsed and if all treatment-related toxicity has been resolved to Grade .1

- Prior palliative radiotherapy must have been completed at least 7 days before the
first dose of AMG 757

- Subjects who experienced immune related pneumonitis, pituitary or thyroid dysfunction,
or pancreatitis while on treatment with immuno-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 AMG
757

- Live vaccination is not allowed for at least 4 weeks prior to the start of AMG 757
treatment, during treatment, and until end of last study dose

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Single group
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - 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
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
France
State/province [6] 0 0
Villejuif
Country [7] 0 0
Germany
State/province [7] 0 0
Wurzburg
Country [8] 0 0
Japan
State/province [8] 0 0
Chiba

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 pharmacokinetics of AMG 757 in Subjects with
Small Cell Lung Cancer
Trial website
https://clinicaltrials.gov/show/NCT03319940
Trial related presentations / publications
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

No data has been provided for results reporting
Summary results
Not applicable