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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05800964




Registration number
NCT05800964
Ethics application status
Date submitted
24/03/2023
Date registered
6/04/2023

Titles & IDs
Public title
Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
Scientific title
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
Secondary ID [1] 0 0
2022-502867-39
Secondary ID [2] 0 0
20220073
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 305

Experimental: Part A: Dose Exploration - Participants will receive escalating doses of AMG 305.

Experimental: Part B: Dose Expansion - Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, and other solid tumors will receive the RP2D identified in Part A.


Treatment: Drugs: AMG 305
Short-term intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Day 1 to Day 28
Primary outcome [2] 0 0
Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to a maximum of 2 years
Primary outcome [3] 0 0
Percentage of Participants who Experience Treatment-Related Adverse Events
Timepoint [3] 0 0
Up to a maximum of 2 years
Secondary outcome [1] 0 0
Maximum Serum Concentration (Cmax) of AMG 305
Timepoint [1] 0 0
Up to a maximum of 2 years
Secondary outcome [2] 0 0
Minimum Serum Concentration (Cmin) of AMG 305
Timepoint [2] 0 0
Up to a maximum of 2 years
Secondary outcome [3] 0 0
Area Under the Concentration-Time Curve (AUC) of AMG 305
Timepoint [3] 0 0
Up to a maximum of 2 years
Secondary outcome [4] 0 0
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Timepoint [4] 0 0
Up to a maximum of 2 years
Secondary outcome [5] 0 0
ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Timepoint [5] 0 0
Up to a maximum of 2 years
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
Up to a maximum of 2 years
Secondary outcome [7] 0 0
Time to Progression
Timepoint [7] 0 0
Up to a maximum of 2 years
Secondary outcome [8] 0 0
Progression-Free Survival (PFS)
Timepoint [8] 0 0
Up to a maximum of 2 years
Secondary outcome [9] 0 0
Overall Survival (OS) at 1 Year
Timepoint [9] 0 0
1 year
Secondary outcome [10] 0 0
OS at 2 Years
Timepoint [10] 0 0
2 years

Eligibility
Key inclusion criteria
Key

Pre-screening:

* Participant has provided informed consent prior to initiation of any pre screening study specific activities/procedures.
* Participants with histologically or cytologically documented solid tumor diseases expressing cadherin-3 and mesothelin (by mRNA in the Cancer Genome Atlas Program [TCGA] database), including CRC, NSCLC, mesothelioma, pancreatic cancer, gastric cancer, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer

Clinical study:

* Participant has provided inform consent to the main study prior to initiation of any study specific activities/procedures
* Male or female participants age = 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Participants with histologically or cytologically documented solid tumor diseases, including CRC, NSCLC, mesothelioma, pancreatic cancer, GC, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy
* For dose expansion cohorts: participants with at least 1 measurable lesion =10 mm 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 function

Key
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
* History of other malignancy within the past 2 years
* Ongoing or active infection
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Known interstitial lung disease
* Positive test for human immunodeficiency virus (HIV)
* Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
* Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors (TKI) within 4 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
* Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease)
* Live and/or live-attenuated vaccines received within 28 days (or longer, if required locally) prior to the first dose of AMG 305
* Currently receiving treatment in another investigational device or drug study
* Female participants of childbearing potential or male participants unwilling to use protocol specified method of contraception
* Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant while on study
* 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
Other
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/08/2027
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris OBrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
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
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
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
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
France
State/province [8] 0 0
Toulouse cedex 9
Country [9] 0 0
France
State/province [9] 0 0
Villejuif
Country [10] 0 0
Germany
State/province [10] 0 0
Dresden
Country [11] 0 0
Germany
State/province [11] 0 0
Essen
Country [12] 0 0
Germany
State/province [12] 0 0
Wuerzburg
Country [13] 0 0
Japan
State/province [13] 0 0
Chiba
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Spain
State/province [15] 0 0
Cataluña
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

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
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
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/NCT05800964