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A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
NCT05975073 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG AMG 193
- DRUG IDE397
Study Locations (20)
New York
- New York University Grossman School of Medicine and New York University Langone Hospitals — New York
- Columbia University Irving Medical Center — New York
- Memorial Sloan Kettering Cancer Center — New York
Texas
- University of Texas MD Anderson Cancer Center — Houston
- Next Oncology — Irving
Other
- Rigshospitalet — Copenhagen
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do
California
- City of Hope National Medical Center — Duarte
Colorado
- Sarah Cannon Research Institute — Denver
Indiana
- Community Health Network MD Anderson Cancer Center - North — Indianapolis
Massachusetts
- Dana Farber Cancer Institute — Boston
Michigan
- University of Michigan — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05975073
The ClinicalTrials.gov registry entry for NCT05975073 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with MTAP-null Non-Small-Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which AMG 193 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05975073 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New York, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05975073 about?
NCT05975073 is a clinical study titled "A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors". 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 p...
What is the current status of trial NCT05975073?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2023-08-01. Estimated completion is 2026-04-01.
What conditions does trial NCT05975073 study?
This clinical trial studies the following conditions: MTAP-null Non-Small-Cell Lung Cancer, MTAP-null Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05975073?
The interventions under investigation include: AMG 193 (DRUG), IDE397 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05975073?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05975073 being conducted?
This trial has 20 study locations across California, Colorado, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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