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NCT06593522

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

Active, Not Recruiting
PHASE2Ages 18–99InterventionalTreatment
Amgen
~61 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:anvumetostat

At a glance

Recruiting sites
0 of 91 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response (OR) per RECIST 1.1
Measured over Up to 35 months
+6 more outcomes measured

Conditions

MTAP-deleted NSCLC

Explore related trials

Lung Non-Small Cell CarcinomaMTAP Gene

Where it's being run

91 sites across 46 states
California5
Texas5
Turkey (Türkiye)5
São Paulo4
Czechia4
Portugal4
South Korea4
Ontario3

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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

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.

What this trial measures

  • Objective Response (OR) per RECIST 1.1Up to 35 months
  • Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)Up to 35 months
  • Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)Up to 35 months
  • Number of Participants Experiencing Events of Interest (EOIs)Up to 35 months
  • Maximum Concentration (Cmax) of anvumetostatCycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
  • Time to Cmax (Tmax) of anvumetostatCycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
  • Area Under The Concentration-time Curve (AUC) of anvumetostatCycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose