A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC

Trial Title: A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC

NCT ID: NCT06593522

Condition: MTAP-deleted NSCLC

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Oncology
AMG 193

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: AMG 193
Description: Film-coated tablet
Arm group label: Part 1: Dose Evaluation
Arm group label: Part 2: Dose Expansion

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).

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Start date: December 18, 2024

Completion date: September 12, 2029

Lead sponsor:
Agency: Amgen
Agency class: Industry

Source: Amgen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06593522
http://www.amgentrials.com