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

NCT06333951 · tracked via the Priya Life Science China tracker

Sponsor

Amgen

Phase

Phase 1

Started

2024-09-17

Last updated

2026-05-28

Condition(s) studied

Thoracic TumorsNon-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

AnvumetostatCarboplatinPaclitaxelPembrolizumabPemetrexedSotorasib

Anvumetostat: Administered PO

Carboplatin: Administered IV

Paclitaxel: Administered IV

Pembrolizumab: Administered IV

Pemetrexed: Administered IV

Sotorasib: Administered PO

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

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'

Primary outcome measure(s)

Number of Participants Experiencing Dose Limiting Toxicities (DLT) — Up to approximately 21 days
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) — Up to approximately 3 years
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Number of Participants Experiencing Serious Adverse Events (SAE) — Up to approximately 3 years
An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.

Trial sites (83)

Facility	City	Region
Comprehensive Blood and Cancer Center	Bakersfield	California
City of Hope National Medical Center	Duarte	California
City of Hope Orange County Lennar Foundation Cancer Center	Duarte	California
Translational Research in Oncology US Inc, Trio Central Pharmacy	Los Angeles	California
University of California Irvine	Orange	California
University of California Los Angeles	Santa Monica	California
Rocky Mountain Cancer Centers	Denver	Colorado
Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
HealthPartners Institute	Saint Paul	Minnesota
Saint Lukes Hospital of Kansas City	Kansas City	Missouri
Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
Roswell Park Cancer Institute	Buffalo	New York
New York University Grossman School of Medicine	New York	New York
Perlmutter Cancer Center at New York University Langone Hospital----Long Island	New York	New York
Upstate University Hospital	Syracuse	New York
Hightower Clinical	Oklahoma City	Oklahoma
Fox Chase Cancer Center	Philadelphia	Pennsylvania
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
University of Tennessee Medical Center Knoxville	Knoxville	Tennessee
United States Oncology Regulatory Affairs Corporate Office	Nashville	Tennessee
Texas Oncology - Dallas Fort Worth	Dallas	Texas
US Oncology Research Investigational Products Center	Dallas	Texas
Oncology Consultants Cancer Center	Houston	Texas
Texas Oncology Northeast Texas	Tyler	Texas
Virginia Cancer Specialists PC	Fairfax	Virginia
Northwest Medical Specialties, PLLC	Tacoma	Washington
Instituto Argentino de Diagnóstico y Tratamiento	Ciudad Automona de Buenos Aires	Buenos Aires
Hospital Universitario Austral	Pilar	Buenos Aires
Cemic	Ciudad Autonoma Buenos Aires	Argentina
Orange Health Service	Orange	New South Wales
The Queen Elizabeth Hospital	Woodville South	South Australia
Medizinische Universitaet Graz	Graz	Austria
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Centre Hospitalier Universitaire de Liege - Sart Tilman	Liège	Belgium
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda	Ijuí	Rio Grande do Sul
Cipo - Centro Integrado de Pesquisa em Oncologia	Porto Alegre	Rio Grande do Sul
Fund Faculdade Regional Med Sao Jose Rio Preto	São José do Rio Preto	São Paulo
Beneficencia Portuguesa de Sao Paulo - Bp	São Paulo	São Paulo
Instituto Cancer Sao Paulo Icesp	São Paulo	Brazil
Princess Margaret Cancer Centre	Toronto	Ontario

+ 43 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06333951 on ClinicalTrials.gov ↗ ← All trials in China