The Phase II MTAPESTRY 201 trial evaluates the investigational agent AMG 193 in adults with histologically or cytologically confirmed, metastatic or unresectable locally advanced non-small cell lung cancer (NSCLC) harboring a homozygous deletion of the MTAP gene. The primary objective is to characterize the safety, tolerability, pharmacokinetics and efficacy of two dose levels of AMG 193 via investigator assessment and a Blinded Independent Central Review (BICR). Key inclusion criteria include prior systemic therapy, availability of archived tumor tissue, life expectancy greater than three months, and treated or stable brain metastases = 2 cm without need for corticosteroids. The molecular status (MTAP homozygous deletion) is confirmed during screening; patients with actionable driver mutations (EGFR, ALK, ROS1, NTRK, MET, BRAF, RET, HER2, KRAS G12C) are excluded. Treatment is administered orally once daily in 28-day cycles in a sequential dose-escalation and expansion design. Important secondary endpoints include safety profiles, PK parameters and preliminary response rates.
This trial is investigating the investigational drug AMG 193 in adults with advanced non-small cell lung cancer whose tumors carry a homozygous deletion of the MTAP gene. The aim is to evaluate how safe and tolerable AMG 193 is, and whether it shows signs of activity in this specific patient population. Eligible participants have previously received at least one systemic therapy and have either unresectable locally advanced or metastatic disease. The molecular status (MTAP deletion) is confirmed via tumor tissue. Treatment is given orally in 28-day cycles with two dose levels: first a dose-finding phase followed by a dose-expansion phase. Key outcomes include safety, tolerability and early efficacy signals.
