A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
NCT ID: NCT05975073
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
53 participants
INTERVENTIONAL
2023-08-01
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
AMG 193
Administered PO
IDE397
Administered PO
Part 2: Dose Expansion of AMG 193 Combined With IDE397
AMG 193 and IDE397 will be administered PO in cycles of 21 days.
AMG 193
Administered PO
IDE397
Administered PO
Interventions
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AMG 193
Administered PO
IDE397
Administered PO
Eligibility Criteria
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Inclusion Criteria
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
2. Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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City of Hope National Medical Center
Duarte, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Community Health Network MD Anderson Cancer Center - North
Indianapolis, Indiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Health Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Prisma Health Upstate
Greenville, South Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Next Oncology
Irving, Texas, United States
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Rigshospitalet
Copenhagen, , Denmark
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20220127
Identifier Type: -
Identifier Source: org_study_id