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Recruitment Complete
Sponsor ID
20230167

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

Sponsor ID
20230167
Clinicaltrials.gov ID
NCT06333951
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

Additional Study Details

Phase
Phase 1
Product
AMG 193
Type
Interventional
Masking
None (Open Label)
Enrollment
49
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants Experiencing Dose Limiting Toxicities (DLT)

Timeframe: Up to approximately 21 days

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

Timeframe: Up to approximately 3 years

Number of Participants Experiencing Serious Adverse Events (SAE)

Timeframe: Up to approximately 3 years

Secondary Outcome Measures

Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Timeframe: Up to approximately 3 years

Disease Control (DC) per RECIST v1.1

Timeframe: Up to approximately 3 years

Duration of Response (DOR) per RECIST v1.1

Timeframe: Up to approximately 3 years

Time to Response (TTR) per RECIST v1.1

Timeframe: Up to approximately 3 years

Overall Survival (OS) per RECIST v1.1

Timeframe: Up to approximately 3 years

Progression-free Survival (PFS) per RECIST v1.1

Timeframe: Up to approximately 3 years

Maximum Plasma Concentration (Cmax) of Anvumetostat

Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 days)

Time to Maximum Plasma Concentration (tmax) of Anvumetostat

Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 days)

Area Under the Plasma Concentration-time Curve (AUC) of Anvumetostat

Timeframe: Up to Day 1 of Cycle 5 (one cycle = 21 days)

Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM )

Timeframe: Up to approximately 3 years

Intracranial Disease Control (IDC) per RANO-BM

Timeframe: Up to approximately 3 years

Intracranial Duration of Response (IDOR) per RANO-BM

Timeframe: Up to approximately 3 years

Time to Intracranial Radiation Therapy per RANO-BM

Timeframe: Up to approximately 3 years

Locations

Location
Status
Contact Us
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Terminated
Location
Comprehensive Blood and Cancer Center
Bakersfield, CA, United States, 93309
Status
Recruiting
Location
Comprehensive Cancer Centers of Nevada
Las Vegas, NV, United States, 89169
Status
Terminated
Location
University of Tennessee Medical Center Knoxville
Knoxville, TN, United States, 37920
Status
Recruiting
Location
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, CA, United States, 91010
Status
Terminated
Location
Translational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, CA, United States, 90095
Status
Recruiting
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Study Info
Age
18 - 100 Years
Condition
  • Tumor
    • Show more
  • Lung Cancer - Non-Small Cell
    • Sex
    All
    Trial Dates
    Sep 2024 - Oct 2026
    Inclusion and Exclusion Criteria
    Inclusion Criteria Subprotocol A, B, and C - Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years). - Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before Anvumetostat dosing. - Homozygous MTAP-deletion - Able to swallow and retain PO administered study treatment. - Disease measurable as defined by RECIST v1.1. Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC. Arm A (Anvumetostat + carboplatin + paclitaxel + pembrolizumab): - Predominantly squamous histology. Arm B (Anvumetostat + carboplatin + pemetrexed + pembrolizumab): - Predominantly non-squamous histology. Arm C (Anvumetostat + pembrolizumab): - PD-L1 positive. Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation. Subprotocol C - Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases. - Brain lesion meeting RANO-BM criteria for measurable disease. Exclusion Criteria Subprotocol A, B, and C - Cardiovascular and pulmonary exclusion criteria as defined in the protocol. - Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis). - History of solid organ transplant. - Major surgery within 28 days of first dose of Anvumetostat. - Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor. - Radiation therapy within 28 days of first dose. Subprotocol A - Autoimmune disease or immunodeficiency disease as defined in the protocol’