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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05975073




Registration number
NCT05975073
Ethics application status
Date submitted
19/07/2023
Date registered
3/08/2023

Titles & IDs
Public title
A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
Scientific title
A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors
Secondary ID [1] 0 0
20220127
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MTAP-null Non-Small-Cell Lung Cancer 0 0
MTAP-null Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMG 193
Treatment: Drugs - IDE397

Experimental: Part 1: Dose Exploration of AMG 193 Combined With IDE397 - Participants will receive escalating doses of AMG 193 and IDE397 administered orally (PO) in cycles of 21 days.

Experimental: Part 2: Dose Expansion of AMG 193 Combined With IDE397 - AMG 193 and IDE397 will be administered PO in cycles of 21 days.


Treatment: Drugs: AMG 193
Administered PO

Treatment: Drugs: IDE397
Administered PO
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Day 1 up to Day 21
Primary outcome [2] 0 0
Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Day 1 up to approximately 2.5 years
Primary outcome [3] 0 0
Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Day 1 up to approximately 2.5 years
Primary outcome [4] 0 0
Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Timepoint [4] 0 0
Day 1 up to approximately 2.5 years
Secondary outcome [1] 0 0
Part 1 and 2: Maximal Plasma Concentration (Cmax) of AMG 193
Timepoint [1] 0 0
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Secondary outcome [2] 0 0
Part 1 and 2: Cmax of IDE397
Timepoint [2] 0 0
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Secondary outcome [3] 0 0
Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193
Timepoint [3] 0 0
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Secondary outcome [4] 0 0
Part 1 and 2: Tmax of IDE397
Timepoint [4] 0 0
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Secondary outcome [5] 0 0
Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of AMG 193
Timepoint [5] 0 0
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Secondary outcome [6] 0 0
Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of AMG 193
Timepoint [6] 0 0
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Secondary outcome [7] 0 0
Parts 1 and 2: AUC After Single Dose of IDE397
Timepoint [7] 0 0
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Secondary outcome [8] 0 0
Parts 1 and 2: AUC After Multiple Doses of IDE397
Timepoint [8] 0 0
Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
Secondary outcome [9] 0 0
Parts 1: Overall Response per RECIST 1.1
Timepoint [9] 0 0
Day 1 up to end-of-study (EOS) (approximately 2.5 years)
Secondary outcome [10] 0 0
Parts 1 and 2: Disease Control Rate
Timepoint [10] 0 0
Day 1 up to EOS (approximately 2.5 years)
Secondary outcome [11] 0 0
Parts 1 and 2: Time to Response (TTR)
Timepoint [11] 0 0
Day 1 up to EOS (approximately 2.5 years)
Secondary outcome [12] 0 0
Parts 1 and 2: Duration of Response (DOR)
Timepoint [12] 0 0
Day 1 up to EOS (approximately 2.5 years)
Secondary outcome [13] 0 0
Parts 1 and 2: Duration of Stable Disease
Timepoint [13] 0 0
Day 1 up to EOT (approximately 6 months)
Secondary outcome [14] 0 0
Parts 1 and 2: Progression-free Survival (PFS)
Timepoint [14] 0 0
Day 1 up to EOS (approximately 2.5 years)
Secondary outcome [15] 0 0
Parts 1 and 2: Overall Survival (OS)
Timepoint [15] 0 0
Day 1 up to EOS (approximately 2.5 years)
Secondary outcome [16] 0 0
Part 2: Number of Participants Experiencing TEAEs
Timepoint [16] 0 0
Day 1 up to approximately 2.5 years
Secondary outcome [17] 0 0
Part 2: Number of Participants Experiencing SAEs
Timepoint [17] 0 0
Day 1 up to approximately 2.5 years
Secondary outcome [18] 0 0
Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood
Timepoint [18] 0 0
Baseline (Day 1) to EOT plus 30 days (approximately 7 months)

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
2. Presence of advanced/metastatic solid tumor not amenable to curative treatment

1. Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
2. Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
3. Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
4. Disease measurable as defined by RECIST v1.1
5. Adequate organ function as defined in the protocol.
6. Archived tumor tissue. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before cycle 1 day 1 dosing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
3. Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
4. 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)
5. History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
6. Prior irradiation to > 25% of the bone marrow
7. Use of prescription medications that are known strong CYP3A4/5 inducers or strong CYP3A4/5 inhibitors within 7 days for CYP3A4/5 inhibitors, 14 days for CYP3A4/5 inducers or 5 half-lives, whichever is longer, prior to any dose of investigational medical product.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/09/2027
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
3168 - Clayton
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
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Denmark
State/province [14] 0 0
Copenhagen
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Spain
State/province [16] 0 0
Cataluña
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Taiwan
State/province [18] 0 0
Tainan
Country [19] 0 0
Taiwan
State/province [19] 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 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: https://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/NCT05975073