Status:
ACTIVE_NOT_RECRUITING
A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
Lead Sponsor:
Amgen
Conditions:
MTAP-null Non-Small-Cell Lung Cancer
MTAP-null Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Evidence of homozygous loss of MTAP (null) and/or MTAP deletion.
- Presence of advanced/metastatic solid tumor not amenable to curative treatment
- Part 1: MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
- Part 2: MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy.
- Able to swallow and retain PO administered study treatment and willing to record adherence to investigational product
- Disease measurable as defined by RECIST v1.1
- Adequate organ function as defined in the protocol.
- 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
- Prior treatment with an MAT2A inhibitor or a PRMT5 inhibitor.
- Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease.
- 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 bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study entry.
- Prior irradiation to \> 25% of the bone marrow
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05975073
Start Date
August 1 2023
End Date
April 1 2026
Last Update
December 23 2025
Active Locations (27)
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1
City of Hope National Medical Center
Duarte, California, United States, 91090
2
Sarah Cannon Research Institute
Denver, Colorado, United States, 80218
3
Community Health Network MD Anderson Cancer Center - North
Indianapolis, Indiana, United States, 46250
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215