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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/NCT05975073
Registration number
NCT05975073
Ethics application status
Date submitted
19/07/2023
Date registered
3/08/2023
Date last updated
6/06/2024
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
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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
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Secondary ID [1]
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20220127
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
MTAP-null Non-Small-Cell Lung Cancer
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MTAP-null Solid Tumors
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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Timepoint [1]
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Day 1 up to Day 21
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Primary outcome [2]
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Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
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Assessment method [2]
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Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
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Timepoint [2]
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Day 1 up to approximately 2.5 years
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Primary outcome [3]
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Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [3]
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Timepoint [3]
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Day 1 up to approximately 2.5 years
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Primary outcome [4]
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Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
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Assessment method [4]
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Timepoint [4]
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Day 1 up to approximately 2.5 years
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Secondary outcome [1]
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Part 1 and 2: Maximal Plasma Concentration (Cmax) of AMG 193
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Assessment method [1]
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Timepoint [1]
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Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
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Secondary outcome [2]
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Part 1 and 2: Cmax of IDE397
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Assessment method [2]
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Timepoint [2]
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Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
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Secondary outcome [3]
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Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193
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Assessment method [3]
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Timepoint [3]
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Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
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Secondary outcome [4]
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Part 1 and 2: Tmax of IDE397
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Assessment method [4]
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Timepoint [4]
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Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
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Secondary outcome [5]
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Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of AMG 193
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Assessment method [5]
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Timepoint [5]
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Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
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Secondary outcome [6]
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Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of AMG 193
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Assessment method [6]
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Timepoint [6]
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Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
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Secondary outcome [7]
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Parts 1 and 2: AUC After Single Dose of IDE397
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Assessment method [7]
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Timepoint [7]
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Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
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Secondary outcome [8]
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Parts 1 and 2: AUC After Multiple Doses of IDE397
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Assessment method [8]
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Timepoint [8]
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Day 1 pre-dose up to Cycle 5 (Cycle= 21 days)
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Secondary outcome [9]
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Parts 1: Overall Response per RECIST 1.1
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Assessment method [9]
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Timepoint [9]
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Day 1 up to end-of-study (EOS) (approximately 2.5 years)
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Secondary outcome [10]
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Parts 1 and 2: Disease Control Rate
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Assessment method [10]
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Timepoint [10]
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Day 1 up to EOS (approximately 2.5 years)
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Secondary outcome [11]
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Parts 1 and 2: Time to Response (TTR)
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Assessment method [11]
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Timepoint [11]
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Day 1 up to EOS (approximately 2.5 years)
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Secondary outcome [12]
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Parts 1 and 2: Duration of Response (DOR)
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Assessment method [12]
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Timepoint [12]
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Day 1 up to EOS (approximately 2.5 years)
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Secondary outcome [13]
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Parts 1 and 2: Duration of Stable Disease
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Assessment method [13]
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Timepoint [13]
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Day 1 up to EOT (approximately 6 months)
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Secondary outcome [14]
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Parts 1 and 2: Progression-free Survival (PFS)
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Assessment method [14]
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Timepoint [14]
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Day 1 up to EOS (approximately 2.5 years)
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Secondary outcome [15]
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Parts 1 and 2: Overall Survival (OS)
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Assessment method [15]
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Timepoint [15]
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Day 1 up to EOS (approximately 2.5 years)
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Secondary outcome [16]
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Part 2: Number of Participants Experiencing TEAEs
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Assessment method [16]
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Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
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Timepoint [16]
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Day 1 up to approximately 2.5 years
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Secondary outcome [17]
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Part 2: Number of Participants Experiencing SAEs
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Assessment method [17]
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Timepoint [17]
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Day 1 up to approximately 2.5 years
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Secondary outcome [18]
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Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood
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Assessment method [18]
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Timepoint [18]
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Baseline (Day 1) to EOT plus 30 days (approximately 7 months)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/07/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/12/2026
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Actual
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Sample size
Target
184
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [2]
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Monash Medical Centre - Clayton
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Recruitment postcode(s) [1]
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5011 - Woodville South
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Indiana
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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New Jersey
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Country [6]
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United States of America
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State/province [6]
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New York
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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United States of America
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State/province [8]
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South Carolina
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Country [9]
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United States of America
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State/province [9]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main aims of this study are to evaluate the safety and tolerability, and to determine the
maximum tolerated dose (MTD) or the recommended combination dose of AMG 193 in combination
with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors,
and to evaluate the preliminary anti-tumor activity of AMG 193 in combination with IDE397 in
adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer
(NSCLC).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05975073
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amgen Call Center
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Address
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Country
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Phone
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866-572-6436
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05975073
Download to PDF