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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05317078




Registration number
NCT05317078
Ethics application status
Date submitted
30/03/2022
Date registered
7/04/2022

Titles & IDs
Public title
A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications
Scientific title
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 794 in Participants With Claudin 6-positive Advanced/Metastatic Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications
Secondary ID [1] 0 0
20210007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-squamous Non-small Cell Lung Cancer 0 0
Epithelial Ovarian Cancer 0 0
Claudin 6-positive Advanced/Metastatic Malignant Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 794

Experimental: Part 1: AMG 794 Monotherapy Dose Exploration - Participants with claudin 6 (CLDN6)-positive advanced/metastatic non-squamous non-small cell lung cancer (NSCLC), epithelial ovarian cancer (EOC), or other solid tumor indications will be treated in up to 11 multiple ascending cohorts with additional participants optionally enrolled in dose exploration cohorts with target dose levels that have previously been shown to be safe and tolerable.

Experimental: Part 2: AMG 794 Monotherapy Dose Expansion - Participants with CLDN6-positive advanced/metastatic NSCLC, EOC, or other solid tumor indications will be treated with the OBD of AMG 794 identified in Part 1.


Treatment: Drugs: AMG 794
Short-term intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
Day 1 to Day 28
Primary outcome [2] 0 0
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timepoint [2] 0 0
Day 1 to a maximum of 2 years
Primary outcome [3] 0 0
Number of Participants Who Experience a Treatment-related AE
Timepoint [3] 0 0
Day 1 to a maximum of 2 years
Secondary outcome [1] 0 0
Minimum Efficacious Dose (MED)
Timepoint [1] 0 0
Day 1 to a maximum of 2 years
Secondary outcome [2] 0 0
Maximum Observed Serum Concentration (Cmax) of AMG 794
Timepoint [2] 0 0
Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)
Secondary outcome [3] 0 0
Minimum Observed Serum Concentration (Cmin) of AMG 794
Timepoint [3] 0 0
Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)
Secondary outcome [4] 0 0
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 794
Timepoint [4] 0 0
Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)
Secondary outcome [5] 0 0
Confirmed objective response (OR)
Timepoint [5] 0 0
Day 1 to a maximum of 2 years
Secondary outcome [6] 0 0
Confirmed OR
Timepoint [6] 0 0
Day 1 to a maximum of 2 years
Secondary outcome [7] 0 0
Cancer Antigen (CA) 125 Response
Timepoint [7] 0 0
Day 1 to a maximum of 2 years
Secondary outcome [8] 0 0
Duration of Response
Timepoint [8] 0 0
Day 1 to a maximum of 2 years
Secondary outcome [9] 0 0
Time to Progression
Timepoint [9] 0 0
Day 1 to a maximum of 2 years
Secondary outcome [10] 0 0
Progression-free Survival (PFS)
Timepoint [10] 0 0
Day 1 to a maximum of 2 years
Secondary outcome [11] 0 0
1-year Overall Survival (OS)
Timepoint [11] 0 0
1 year
Secondary outcome [12] 0 0
2-year OS
Timepoint [12] 0 0
2 years

Eligibility
Key inclusion criteria
Pre-screening:

* Age = 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1.
* Participants with histologically or cytologically documented malignant solid tumor diseases expressing claudin-6 (CLDN6) including but not limited to NSCLC, EOC, testicular germ cell cancer, uterine endometrial cancer, or triple negative breast cancer, and the cancer is at least either locally advanced or metastatic at pre-screening.
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.

Main study:

* Age = 18 years.
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* ECOG performance status of 0 to 1.
* Participants with histologically or cytologically documented malignant solid tumor diseases expressing CLDN6 including but not limited to NSCLC, EOC, testicular germ cell cancer, uterine endometrial cancer, or triple negative breast cancer, that is metastatic or unresectable at screening time point. Participants should have exhausted available SOC systemic therapy or should not be candidates for such available therapy.
* For participants enrolling in cohort 3 or higher dose cohort, available positive test result for CLDN6 expression resulting from testing of an available archival tissue sample in pre-screening or obtained from biopsy in a screening procedure. For participants enrolling in cohorts 1, 1a, or 2 during dose escalation, consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment is sufficient and the enrolment is not dependent on availability of the CLDN6 expression test result.
* For dose expansion cohorts: Participants with at least 1 measurable lesion = 10mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study.
* Life expectancy > 3 months.
* Adequate organ functions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Main study:

* Positive test for human immunodeficiency virus, hepatitis B or hepatitis C.
* History of other malignancy 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 with 1 week prior to administration of a first dose of study treatment
* Evidence of new or growing central nervous system metastases, leptomeningeal disease, or spinal cord compression. Participants with known brain metastases may be eligible if they completed radiotherapy, surgery or stereotactic surgery for the brain metastases and do not present with neurological symptoms and/or have stable disease assessed by imaging within 4 weeks of signing consent to this study and not requiring acute corticosteroid therapy or steroid taper.
* Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Anticancer therapies including radiotherapy, chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of administration of a first dose of study treatment; immunotherapies/monoclonal antibodies within 3 weeks of administration of a first dose of study treatment.
* Has had a major surgery within 4 weeks of administration of a first dose of study treatment (excluded: biopsies and central venous catheter insertion).
* Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study, (e.g., ulcerative colitis, Crohn's disease). Recent or current use of inhaled steroids or physiological substitution in case of adrenal insufficiency is not exclusionary.
* Female participants who are of childbearing potential unwilling to use protocol-specified method of contraception, who are breastfeeding and/or planning to become pregnant.
* Male participants who have a female partner of childbearing potential who are unwilling to practice sexual abstinence or use protocol-specified contraception and/or who are unwilling to abstain from donating sperm.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/12/2023
Sample size
Target
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Southern Oncology Clinical Research Unit - Bedford Park
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Cabrini Hospital - Malvern
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3144 - Malvern
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
Virginia
Country [3] 0 0
Switzerland
State/province [3] 0 0
Bern

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05317078