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NCT Number: NCT06593522

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

The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

MTAP-deleted NSCLC Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GenesisCare -North Shore Oncology, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Anvumetostat

Drug

Film-coated tablet

Primary outcomes

  1. Objective Response (OR) per RECIST 1.1

    Time frame: Up to 35 months

  2. 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)

    Time frame: Up to 35 months

  3. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 35 months

  4. Number of Participants Experiencing Events of Interest (EOIs)

    Time frame: Up to 35 months

  5. Maximum Concentration (Cmax) of anvumetostat

    Time frame: Cycle 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

  6. Time to Cmax (Tmax) of anvumetostat

    Time frame: Cycle 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

  7. Area Under The Concentration-time Curve (AUC) of anvumetostat

    Time frame: Cycle 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

Secondary outcomes

  1. Disease Control (DC) by BICR

    Time frame: Up to 35 months

  2. Duration of Response (DOR) by BICR

    Time frame: Up to 35 months

  3. Time to Response (TTR) by BICR

    Time frame: Up to 35 months

  4. Progression-free Survival (PFS) by BICR

    Time frame: Up to 35 months

  5. OR by Investigator's Assessment

    Time frame: Up to 35 months

  6. DC by Investigator's Assessment

    Time frame: Up to 35 months

  7. DOR by Investigator's Assessment

    Time frame: Up to 35 months

  8. TTR by Investigator's Assessment

    Time frame: Up to 35 months

  9. PFS by Investigator's Assessment

    Time frame: Up to 35 months

  10. Overall Survival (OS)

    Time frame: Up to 35 months

  11. Number of Participants Experiencing TEAEs

    Time frame: Up to 35 months

  12. Cmax of anvumetostat

    Time frame: Cycle 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

  13. Tmax of anvumetostat

    Time frame: Cycle 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

  14. AUC of anvumetostat

    Time frame: Cycle 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

  15. Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30

    Time frame: Up to 12 months

  16. Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ LC13)

    Time frame: Up to 12 months

  17. Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)

    Time frame: Up to 12 months

  18. Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Time frame: Up to 12 months

  19. Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G)

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Anvumetostat in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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