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Recruitment Complete
Sponsor ID
20230153

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

Sponsor ID
20230153
Clinicaltrials.gov ID
NCT06593522
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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).

Additional Study Details

Phase
Phase 2
Product
AMG 193
Type
Interventional
Masking
None (Open Label)
Enrollment
61
Additional Study Details

Protocol Summary

Primary Outcome Measures

Objective Response (OR) per RECIST 1.1

Timeframe: Up 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)

Timeframe: Up to 35 months

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

Timeframe: Up to 35 months

Number of Participants Experiencing Events of Interest (EOIs)

Timeframe: Up to 35 months

Maximum Concentration (Cmax) of anvumetostat

Timeframe: 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

Time to Cmax (Tmax) of anvumetostat

Timeframe: 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

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

Timeframe: 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 Outcome Measures

Disease Control (DC) by BICR

Timeframe: Up to 35 months

Duration of Response (DOR) by BICR

Timeframe: Up to 35 months

Time to Response (TTR) by BICR

Timeframe: Up to 35 months

Progression-free Survival (PFS) by BICR

Timeframe: Up to 35 months

OR by Investigator's Assessment

Timeframe: Up to 35 months

DC by Investigator's Assessment

Timeframe: Up to 35 months

DOR by Investigator's Assessment

Timeframe: Up to 35 months

TTR by Investigator's Assessment

Timeframe: Up to 35 months

PFS by Investigator's Assessment

Timeframe: Up to 35 months

Overall Survival (OS)

Timeframe: Up to 35 months

Number of Participants Experiencing TEAEs

Timeframe: Up to 35 months

Cmax of anvumetostat

Timeframe: 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

Tmax of anvumetostat

Timeframe: 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

AUC of anvumetostat

Timeframe: 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

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

Timeframe: Up to 12 months

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

Timeframe: Up to 12 months

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

Timeframe: Up to 12 months

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

Timeframe: Up to 12 months

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

Timeframe: Up to 12 months

Locations

Location
Status
Contact Us
Location
GenesisCare -North Shore Oncology
St Leonards, NSW, Australia, 2065
Status
Recruiting
Location
Calvary Mater Newcastle Hospital
Waratah, NSW, Australia, 2298
Status
Recruiting
Location
McGill University Health Centre Glen Site
Montreal, QC, Canada, H4A 3J1
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
University of California Los Angeles
Los Angeles, CA, United States, 90095
Status
Recruiting
Location
Valkyrie Clinical Trials
Los Angeles, CA, United States, 90067
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Dec 2024 - Oct 2026
    Inclusion and Exclusion Criteria
    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.