Status:
RECRUITING
A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
Lead Sponsor:
Amgen
Conditions:
MTAP-deleted NSCLC
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC
- 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
- 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/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).
- 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.
Key Trial Info
Start Date :
December 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 29 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06593522
Start Date
December 26 2024
End Date
November 29 2030
Last Update
December 12 2025
Active Locations (91)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States, 91010
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067