A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC
Sponsor: Amgen
ClinicalTrials ID:NCT06593522
This Phase 2 study evaluates the safety and efficacy of AMG 193, a film-coated tablet, in participants with MTAP-deleted advanced NSCLC. Eligible participants must have progressed after prior systemic therapy and have a life expectancy over 3 months. Those with treated or small, asymptomatic brain metastases may participate. An archival tissue sample is required.
Patient Parameters
| Parameter | Options |
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Program Overview
The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
- Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
- Either an archival tissue sample or an archival block must be available.
- Life expectancy of greater than 3 months, in the opinion of the investigator.
- Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
- Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.
Exclusion Criteria
Disease Related
• Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2), KRAS proto-oncogene (KRAS).
Other Medical Conditions
- Major surgery within 28 days of study day 1.
- Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 91010 | Duarte | California |
| City of Hope Orange County Lennar Foundation Cancer Center | 91010 | Duarte | California |
| Valkyrie Clinical Trials | 90067 | Los Angeles | California |
| University of California Los Angeles | 90095 | Los Angeles | California |
| Eastern Connecticut Hematology and Oncology Associates | 06360 | Norwich | Connecticut |
| Medstar Georgetown University Hospital | 20007 | Washington | District of Columbia |
| Our Lady of the Lake Cancer Institute | 70808 | Baton Rouge | Louisiana |
| Trinity Health Saint Joseph Mercy Ann Arbor | 48106 | Ann Arbor | Michigan |
| Cancer and Hematology Centers of Western Michigan | 49503 | Grand Rapids | Michigan |
| Sarah Cannon Research Institute Oncology Partners | 37203 | Nashville | Tennessee |
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