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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06333951




Registration number
NCT06333951
Ethics application status
Date submitted
21/03/2024
Date registered
27/03/2024

Titles & IDs
Public title
AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)
Scientific title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)
Secondary ID [1] 0 0
20230167
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thoracic Tumors 0 0
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 193
Treatment: Drugs - Carboplatin
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Sotorasib

Experimental: Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A - Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV)

Experimental: Subprotocol A: NSCLC Arm B - Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV

Experimental: Subprotocol A: NSCLC Arm C - Participants with MTAP-deleted NSCLC will receive a combination of AMG 193 PO and pembrolizumab IV

Experimental: Subprotocol B: NSCLC With KRasG12C Mutation - Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of AM193 and sotorasib PO

Experimental: Subprotocol C: NSCLC With Brain Metastases - Participants with MTAP-deleted NSCLC with brain metastases will receive AMG 193 PO


Treatment: Drugs: AMG 193
Administered PO

Treatment: Drugs: Carboplatin
Administered IV

Treatment: Drugs: Paclitaxel
Administered IV

Treatment: Drugs: Pembrolizumab
Administered IV

Treatment: Drugs: Pemetrexed
Administered IV

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

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Dose Limiting Toxicities (DLT)
Timepoint [1] 0 0
Up to approximately 21 days
Primary outcome [2] 0 0
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)
Timepoint [2] 0 0
Up to approximately 3 years
Primary outcome [3] 0 0
Number of Participants Experiencing Serious Adverse Events (SAE)
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Disease Control (DC) per RECIST v1.1
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Duration of Response (DOR) per RECIST v1.1
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Time to Response (TTR) per RECIST v1.1
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Overall Survival (OS) per RECIST v1.1
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Progression-free Survival (PFS) per RECIST v1.1
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Maximum Plasma Concentration (Cmax) of AMG 193
Timepoint [7] 0 0
Up to Day 1 of Cycle 5 (one cycle = 21 days)
Secondary outcome [8] 0 0
Time to Maximum Plasma Concentration (tmax) of AMG 193
Timepoint [8] 0 0
Up to Day 1 of Cycle 5 (one cycle = 21 days)
Secondary outcome [9] 0 0
Area Under the Plasma Concentration-time Curve (AUC) of AMG 193
Timepoint [9] 0 0
Up to Day 1 of Cycle 5 (one cycle = 21 days)
Secondary outcome [10] 0 0
Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM )
Timepoint [10] 0 0
Up to approximately 3 years
Secondary outcome [11] 0 0
Intracranial Disease Control (IDC) per RANO-BM
Timepoint [11] 0 0
Up to approximately 3 years
Secondary outcome [12] 0 0
Intracranial Duration of Response (IDOR) per RANO-BM
Timepoint [12] 0 0
Up to approximately 3 years
Secondary outcome [13] 0 0
Time to Intracranial Radiation Therapy per RANO-BM
Timepoint [13] 0 0
Up to approximately 3 years

Eligibility
Key inclusion criteria
Inclusion Criteria

Subprotocol A, B, and C

* Age = 18 years (or = legal age within the country if it is older than 18 years).
* Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before AMG 193 dosing.
* Homozygous MTAP-deletion.
* Able to swallow and retain PO administered study treatment.
* Disease measurable as defined by RECIST v1.1.

Subprotocol A

- Histologically or cytologically confirmed diagnosis of NSCLC.

Arm A (AMG 193 + carboplatin + paclitaxel + pembrolizumab):

- Predominantly squamous histology.

Arm B (AMG 193 + carboplatin + pemetrexed + pembrolizumab):

- Predominantly non-squamous histology.

Arm C (AMG 193 + pembrolizumab):

- PD-L1 positive.

Subprotocol B

- Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.

Subprotocol C

* Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
* Brain lesion meeting RANO-BM criteria for measurable disease.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Subprotocol A, B, and C

* Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
* Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
* History of solid organ transplant.
* Major surgery within 28 days of first dose of AMG 193.
* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
* Radiation therapy within 28 days of first dose.

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
17/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/10/2031
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Orange Health Service - Orange
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
2800 - Orange
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Oklahoma
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Hong Kong
State/province [13] 0 0
Shatin, New Territories
Country [14] 0 0
Japan
State/province [14] 0 0
Aichi
Country [15] 0 0
Japan
State/province [15] 0 0
Chiba
Country [16] 0 0
Japan
State/province [16] 0 0
Shizuoka
Country [17] 0 0
Japan
State/province [17] 0 0
Wakayama
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Taiwan
State/province [19] 0 0
Tainan
Country [20] 0 0
Taiwan
State/province [20] 0 0
Taipei

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
medinfo@amgen.com
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 reevaluating 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/NCT06333951