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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/NCT05317078




Registration number
NCT05317078
Ethics application status
Date submitted
30/03/2022
Date registered
7/04/2022
Date last updated
11/01/2024

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
Active, not recruiting
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
23/02/2028
Actual
Sample size
Target
98
Accrual to date
Final
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
The primary objectives of this study are to evaluate the safety and tolerability of AMG 794
in adult participants and to determine the optimal biological active dose (OBD), at or below
the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2
as the maximum tolerated target dose.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05317078
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