The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05975073
Recruitment Status : Recruiting
First Posted : August 3, 2023
Last Update Posted : May 6, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
MTAP-null Non-Small-Cell Lung Cancer MTAP-null Solid Tumors Drug: AMG 193 Drug: IDE397 Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : December 27, 2025
Estimated Study Completion Date : July 20, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Drug: AMG 193
Administered PO

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

Drug: IDE397
Administered PO


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to Day 21 ]
  2. Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to approximately 2.5 years ]
    Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events

  3. Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to approximately 2.5 years ]
  4. Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Day 1 up to approximately 2.5 years ]

Secondary Outcome Measures :
  1. Part 1 and 2: Maximal Plasma Concentration (Cmax) of AMG 193 [ Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) ]
  2. Part 1 and 2: Cmax of IDE397 [ Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) ]
  3. Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193 [ Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) ]
  4. Part 1 and 2: Tmax of IDE397 [ Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) ]
  5. Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of AMG 193 [ Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) ]
  6. Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of AMG 193 [ Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) ]
  7. Parts 1 and 2: AUC After Single Dose of IDE397 [ Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) ]
  8. Parts 1 and 2: AUC After Multiple Doses of IDE397 [ Time Frame: Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) ]
  9. Parts 1: Overall Response per RECIST 1.1 [ Time Frame: Day 1 up to end-of-study (EOS) (approximately 2.5 years) ]
  10. Parts 1 and 2: Disease Control Rate [ Time Frame: Day 1 up to EOS (approximately 2.5 years) ]
  11. Parts 1 and 2: Time to Response (TTR) [ Time Frame: Day 1 up to EOS (approximately 2.5 years) ]
  12. Parts 1 and 2: Duration of Response (DOR) [ Time Frame: Day 1 up to EOS (approximately 2.5 years) ]
  13. Parts 1 and 2: Duration of Stable Disease [ Time Frame: Day 1 up to EOT (approximately 6 months) ]
  14. Parts 1 and 2: Progression-free Survival (PFS) [ Time Frame: Day 1 up to EOS (approximately 2.5 years) ]
  15. Parts 1 and 2: Overall Survival (OS) [ Time Frame: Day 1 up to EOS (approximately 2.5 years) ]
  16. Part 2: Number of Participants Experiencing TEAEs [ Time Frame: Day 1 up to approximately 2.5 years ]
    Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events

  17. Part 2: Number of Participants Experiencing SAEs [ Time Frame: Day 1 up to approximately 2.5 years ]
  18. Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood [ Time Frame: Baseline (Day 1) to EOT plus 30 days (approximately 7 months) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05975073


Contacts
Layout table for location contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
Layout table for location information
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
United States, Indiana
Community Health Network MD Anderson Cancer Center - North Recruiting
Indianapolis, Indiana, United States, 46250
United States, New Jersey
Astera Cancer Care Recruiting
East Brunswick, New Jersey, United States, 08816
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, South Carolina
Prisma Health Upstate Recruiting
Greenville, South Carolina, United States, 29605
United States, Texas
Next Oncology Recruiting
Irving, Texas, United States, 75039
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05975073    
Other Study ID Numbers: 20220127
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: May 6, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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.
URL: https://www.amgen.com/datasharing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Oncology
AMG 193
IDE397
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases