Clinical Trials in the Netherlands / NCT06333951
Active, not recruiting
Phase 1
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 Netherlands tracker
Condition(s) studied
Thoracic TumorsNon-small Cell Lung Cancer
Investigational drug(s) / intervention(s)
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
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 | Status |
|---|---|---|---|
| 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.
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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 the Netherlands