> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-anvumetostat-in-participants-with-advanced-mtap-9ac98870-f390-47a6-8d26-a44da4618937 > Record changed: 2026-10-13 # A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) NCT05094336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) Participants 329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) Start date 2022-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) Number of sites 75 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Title and summary **Summary** The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of Anvumetostat alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the efficacy of Anvumetostat in adult participants with metastatic or locally advanced MTAP-null solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Acronym** MTAPESTRY 101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Short title** A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Official title** A Phase 1/1b/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Dates **Completion date** 2026-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **First posted** 2021-10-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Registry last updated** 2026-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Primary completion date** 2026-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Start date** 2022-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Size and sites **Actual participants** 329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Participants** 329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Protocol amendments** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Number of sites** 75 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Identifiers **Registry ID** NCT05094336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **ClinicalTrials.gov ID** NCT05094336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Outcomes ### Primary outcomes 1. Parts 1 and 2: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) Timeframe: 28 days 2. Parts 1 and 2: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) Timeframe: Up to approximately 3 years Adverse events (AEs) are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs. Serious AEs (SAEs) are defined as any event that meets at least 1 of the following serious criteria: \* Results in death (fatal) \* Requires in-patient hospitalization or prolongation of existing hospitalization \* Results in persistent or significant disability/incapacity \* Is a congenital anomaly/birth defect \* Other medically important serious event 3. Part 3: Objective Response Rate (ORR) Timeframe: Up to approximately 3 years ### Secondary outcomes 1. Parts 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days) 2. Parts 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days) 3. Parts 1 and 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Anvumetostat Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Part 1 Cycle = 28 days, Part 2 Cycle =21 days) 4. Part 2 Only: Maximal Plasma Concentration (Cmax) of Docetaxel Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days) 5. Part 2 Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Docetaxel Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days) 6. Part 2 Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Docetaxel Timeframe: Cycle 1 Day 1 to Pre-Dose Cycle 5 Day 1 (Cycle =21 days) 7. Parts 1 and 2: ORR Timeframe: Up to approximately 3 years 8. Parts 1, 2 and 3: Disease Control Rate (DCR) Timeframe: Up to approximately 3 years 9. Parts 1, 2 and 3: Duration of Response (DoR) Timeframe: Up to approximately 3 years 10. Parts 1, 2 and 3: Time to Response (TTR) Timeframe: Up to approximately 3 years 11. Parts 1, 2 and 3: Duration of Disease Control (DC) Timeframe: Up to approximately 3 years 12. Parts 1, 2 and 3: Progression-Free Survival (PFS) Timeframe: Up to approximately 3 years 13. Parts 1, 2 and 3: Overall Survival (OS) Timeframe: Up to approximately 5 years 14. Part 3 Only: Number of Participants Who Experience TEAE Timeframe: Up to approximately 3 years AEs are defined as any untoward medical occurrence in clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, ECGs and clinical laboratory tests will be recorded as TEAEs. SAEs are defined as any event that meets at least 1 of the following serious criteria: \* Results in death (fatal) \* Requires in-patient hospitalization or prolongation of existing hospitalization \* Results in persistent or significant disability/incapacity \* Is a congenital anomaly/birth defect \* Other medically important serious event 15. Part 1a Only: Maximal Plasma Concentration (Cmax) of Anvumetostat Timeframe: Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days) 16. Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat Timeframe: Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days) 17. Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Anvumetostat Timeframe: Cycle 2 Day 1 to pre-dose on Cycle 2 Day 2 (Cycle = 28 days) 18. Part 1a Only: Maximal Plasma Concentration (Cmax) of Comparator Anvumetostat Test Tablet Timeframe: Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days) 19. Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Comparator Anvumetostat Test Tablet Timeframe: Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days) 20. Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Comparator Anvumetostat Test Tablet Timeframe: Cycle 2 Day 2 to pre-dose on Cycle 2 Day 3 (Cycle = 28 days) 21. Part 1k Only: Cmax of Anvumetostat during fasted state Timeframe: Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days) 22. Part 1k Only: Tmax of Anvumetostat during fasted state Timeframe: Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days) 23. Part 1k Only: AUC of Anvumetostat during fasted state Timeframe: Cycle 2 day 1 pre-dose up to 24 hours post-dose (Cycle = 28 days) 24. Part 1k Only: Cmax of Anvumetostat during fed state Timeframe: Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days) 25. Part 1k Only: Tmax of Anvumetostat during fed state Timeframe: Cycle 2 day 2 pre-dose up to 24 hours post-dose (Cycle = 28 days) And 1 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 100 Years **Healthy volunteers** No ### Inclusion criteria - Participant has provided informed consent/assent before initiation of any study specific activities/procedures. - Age ≥ 18 years. - Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) (Parts 1a, 1j, 1k, and 2a only) and/or methylthioadenosine phosphorylase (MTAP) (null) in the tumor tissue or blood (Parts 1a to 1k, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1k, Parts 2a and 2b). - Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation. - Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product. - Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Note: except participants enrolling to Part 1m. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Adequate hematopoietic function per local laboratory - Adequate renal function per local laboratory - Adequate glucose control per local laboratory (Part 1 only) - Adequate liver function per local laboratory - Adequate coagulation parameters - Adequate pulmonary function - Adequate cardiac function - Minimum life expectancy of 12 weeks as per investigator judgement. - Archived tumor tissue (formalin-fixed, paraffin-embedded \[FFPE\] sample collected within 5 years) or an archival block must be available. - For Part 1f (MTAP-null or lost MTAP expression HNSCC): Must be willing to undergo tumor biopsy. - For Part 1a: Must be willing to undergo tumor biopsy, before start of treatment (archival sample acceptable if obtained with 6 months of enrollment and subject has not received any other treatment since sample was obtained) and while on treatment. - For DSPS study (Part 1j): Must be willing to participate in DSPS substudy (US sites only). Food Effect Substudy (Part 1k): Specific Inclusion Criteria - Subject able and willing to eat a standardized high-fat, high-caloric meal - Subject able and willing to fast for ≥ 6 hours Specific Inclusion Criteria for subjects with glioma (Part 1m only) \- Disease measurable as defined per Modified Response Assessment in Neuro-Oncology Criteria 2.0 (mRANO 2.0) ### Exclusion criteria - Spinal cord compression or untreated brain metastases or leptomeningeal disease. - History of other malignancy within the past 2 years - Any evidence of current interstitial lung disease - Active infection - Evidence of active severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection. - History of arterial thrombosis - Myocardial infarction and/or symptomatic congestive heart failure. - Gastrointestinal tract disease - History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess - History of solid organ transplant. - Diagnosis of Congenital Short QT Syndrome. - Major surgery - Anti-tumor therapy within 28 days of study day 1. - Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor. - Prior treatment with docetaxel (Part 2 only) - Prior irradiation to 25% of the bone marrow. - Therapeutic or palliative radiation therapy within 2 weeks of study day 1. - Live vaccine therapy within 4 weeks before study drug administration. - Use of therapeutic anti-coagulation for treatment of active thromboembolic events. - Use of prescription medications that are known strong inducers of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1 - Unresolved toxicity from prior anti-cancer therapy - Currently receiving treatment in another investigational device or drug study. - Known positive test for Human Immunodeficiency Virus (HIV). - Positive hepatitis B surface antigen - positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR) - Female participants of childbearing potential unwilling to use protocol specified method of contraception Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Sites - City of Hope National Medical CenterDuarte, United States - California Research InstituteGlendale, United States - Fomat Medical ResearchOxnard, United States - University of California at SFSan Francisco, United States - D and H Cancer Research CenterMargate, United States - Boca Raton Clinical Research Medical Center IncTamarac, United States - Goshen Health SystemsGoshen, United States - Indiana UniversityIndianapolis, United States - Community Health Network MD Anderson Cancer Center - NorthIndianapolis, United States - University of Maryland Medical CenterBaltimore, United States - American Oncology Partners, PABethesda, United States - Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)Detroit, United States - Washington UniversitySt Louis, United States - Rutgers Cancer Institute of New JerseyNew Brunswick, United States - Roswell Park Cancer InstituteBuffalo, United States - Northwell Health Monter Cancer CenterLake Success, United States - New York University Grossman School of Medicine and New York University Langone HospitalsNew York, United States - Duke UniversityDurham, United States - University Hospitals Cleveland Medical CenterCleveland, United States - University of PennsylvaniaPhiladelphia, United States - Thomas Jefferson UniversityPhiladelphia, United States - University of Pittsburgh Medical CenterPittsburgh, United States - Sanford Oncology Clinic and PharmacySioux Falls, United States - Sarah Cannon Research InstituteDallas, United States - Center for Oncology and Blood DisordersHouston, United States And 50 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) ### Other registry identifiers (2) - 2023 - 2023-504363-17 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05094336) ## Related records ### Drugs (2) - [Artesunate](https://trialight.com/data/asset/artesunate-586f50f5-bb73-43da-8a18-5a2743da577b.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Conditions (6) - [Biliary tract neoplasm](https://trialight.com/data/condition/biliary-tract-neoplasm-5b757066-5940-52f7-aa7d-e5aafdc5b54e.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Glioma](https://trialight.com/data/condition/glioma-4ac240c4-7ffb-5f08-b793-0b205a4b5d03.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) ### Targets (15) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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