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A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)

Status
Active
Cancer Type
Lung Cancer
Trial Phase
Phase II
Eligibility
18 - 99 Years, Male and Female
Study Type
Treatment
NCT ID
NCT06593522
Protocol IDs
20230153 (primary)
NCI-2024-08984
Study Sponsor
Amgen, Inc.

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 (BICR).

Eligibility

  1. Inclusion Criteria: - 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 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/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.

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.