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MTAPESTRY 101NCT05094336

A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorAmgen
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

The 50 most recent of 71 versions: 49 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 27, 2026 to Nov 30, 2026
    • Study completion moved earlier from May 29, 2028 to Nov 30, 2026
    v71
  2. Primary completion moved earlier from Jun 30, 2026 to May 27, 2026v70 Show 4 more changesShow less
    • Study completion date: May 30, 2028 to May 29, 2028
    • Interventions: AMG 193 (Drug), Comparator AMG 193 Test Tablet (Drug), Docetaxel (Drug) to Anvumetostat (Drug), Comparator Anvumetostat Test Tablet (Drug), Docetaxel (Drug)
    • Secondary endpoints revised (26)
    • Study title shortened, about 1 word
  3. Trial status: Recruiting to Active, Not Recruitingv69 Show 4 more changesShow less
    • Enrollment target: estimated 649 to confirmed 329
    • Primary completion date: Jul 2, 2026 to Jun 30, 2026
    • Study completion date: Jun 1, 2028 to May 30, 2028
    • Site details revised at 75 of 75 sites
  4. Site details revised at 1 of 75 sitesv68
  5. Study sites revised (75)v67
Show 44 earlier versionsHide 44 earlier versions
  1. Primary completion date: Dec 30, 2026 to Jul 2, 2026
    • Study completion date: Nov 27, 2028 to Jun 1, 2028
    • Secondary endpoints: details revised at 8 of 26 entries
    • Site details revised at 3 of 75 sites
    v66
  2. Study sites revised (75)v65
  3. Site details revised at 1 of 75 sitesv63
  4. Site details revised at 1 of 75 sitesv62
  5. Study sites revised (75)v61
  6. Study sites: 74 to 75v60
  7. Study sites: 73 to 74
    • Primary completion date: Aug 2, 2026 to Dec 30, 2026
    • Study completion date: Jun 30, 2028 to Nov 27, 2028
    • Study title expanded, about 2 words
    v59
  8. Study sites: 74 to 73v58
  9. Study sites: 73 to 74v57
  10. Eligibility criteria shortened, about 5 words
    • Study sites revised (73)
    • Study title revised
    v56
  11. Study sites: 72 to 73
    • Study completion date: Jan 29, 2028 to Jun 30, 2028
    v55
  12. Primary completion date: Apr 28, 2026 to Aug 2, 2026
    • Study completion date: Oct 27, 2027 to Jan 29, 2028
    • Study sites revised (72)
    v54
  13. Study sites: 70 to 72v53
  14. Study sites: 69 to 70v52
  15. Study sites: 70 to 69v51
  16. Study sites: 69 to 70v50
  17. Study sites: 68 to 69v49
  18. Study sites: 66 to 68
    • Primary completion date: May 1, 2026 to Apr 28, 2026
    • Study completion date: Oct 30, 2027 to Oct 27, 2027
    v48
  19. Study sites: 65 to 66
    • Primary completion date: Apr 12, 2026 to May 1, 2026
    • Study completion date: Oct 10, 2027 to Oct 30, 2027
    v47
  20. Study sites: 64 to 65
    • Primary completion date: Mar 31, 2026 to Apr 12, 2026
    • Study completion date: Dec 28, 2027 to Oct 10, 2027
    v46
  21. Study sites: 63 to 64v45
  22. Primary completion date: Nov 11, 2027 to Mar 31, 2026
    • Study sites: 60 to 63
    • Study completion date: Mar 12, 2029 to Dec 28, 2027
    v44
  23. Study sites: 59 to 60v43
  24. Study sites: 58 to 59v42
  25. Study sites: 57 to 58v41
  26. Study sites: 56 to 57v40
  27. Eligibility criteria shortened, about 7 wordsv39 Show 5 more changesShow less
    • Enrollment target: 527 to 649
    • Study sites: 53 to 56
    • Secondary endpoints revised (26)
    • Study title shortened, about 12 words
    • Study arms: 12 to 14
  28. Study sites: 52 to 53v38
  29. Study sites revised (52)v37
  30. Study sites: 51 to 52v36
  31. Study sites: 49 to 51v35
  32. Study sites: 44 to 49v34
  33. Primary completion date: Feb 27, 2026 to Nov 11, 2027
    • Study sites: 43 to 44
    • Study completion date: Feb 27, 2028 to Mar 12, 2029
    v33
  34. Study sites: 42 to 43v32
  35. Study sites: 41 to 42v31
  36. Study sites: 40 to 41v30
  37. Primary completion date: Dec 1, 2025 to Feb 27, 2026
    • Study completion date: Dec 1, 2027 to Feb 27, 2028
    • Study sites revised (40)
    v29
  38. Primary completion date: Mar 16, 2025 to Dec 1, 2025v28 Show 5 more changesShow less
    • Eligibility criteria expanded, about 66 words
    • Enrollment target: 386 to 527
    • Study completion date: Feb 28, 2027 to Dec 1, 2027
    • Secondary endpoints: 20 to 26
    • Study arms: 10 to 12
  39. Primary completion date: Aug 27, 2025 to Mar 16, 2025
    • Study completion date: Apr 28, 2028 to Feb 28, 2027
    • Study sites revised (40)
    v27
  40. Study sites: 39 to 40
    • Primary completion date: Oct 14, 2025 to Aug 27, 2025
    • Study completion date: Jun 15, 2028 to Apr 28, 2028
    v26
  41. Study sites: 38 to 39
    • Primary completion date: Oct 31, 2025 to Oct 14, 2025
    • Study completion date: Jul 2, 2028 to Jun 15, 2028
    v25
  42. Study sites: 36 to 38
    • Primary completion date: Sep 8, 2025 to Oct 31, 2025
    • Study completion date: May 8, 2028 to Jul 2, 2028
    v24
  43. Study sites: 34 to 36v23
  44. Study sites: 30 to 34
    • Primary completion date: May 31, 2025 to Sep 8, 2025
    • Study completion date: Jan 29, 2028 to May 8, 2028
    v22
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Parts 1 and 2: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Timeframe: 28 days
Parts 1 and 2: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Up to approximately 3 years
Part 3: Objective Response Rate (ORR)
Timeframe: Up to approximately 3 years

Secondary (26)

Parts 1 and 2: Maximal Plasma Concentration (Cmax) of Anvumetostat
Parts 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat
Parts 1 and 2: Area Under the Plasma Concentration Versus Time Curve (AUC) of Anvumetostat
Part 2 Only: Maximal Plasma Concentration (Cmax) of Docetaxel
Part 2 Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Docetaxel
Show 21 moreShow less
Part 2 Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Docetaxel
Parts 1 and 2: ORR
Parts 1, 2 and 3: Disease Control Rate (DCR)
Parts 1, 2 and 3: Duration of Response (DoR)
Parts 1, 2 and 3: Time to Response (TTR)
Parts 1, 2 and 3: Duration of Disease Control (DC)
Parts 1, 2 and 3: Progression-Free Survival (PFS)
Parts 1, 2 and 3: Overall Survival (OS)
Part 3 Only: Number of Participants Who Experience TEAE
Part 1a Only: Maximal Plasma Concentration (Cmax) of Anvumetostat
Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Anvumetostat
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Anvumetostat
Part 1a Only: Maximal Plasma Concentration (Cmax) of Comparator Anvumetostat Test Tablet
Part 1a Only: Time to Achieve Maximal Plasma Concentration (Tmax) of Comparator Anvumetostat Test Tablet
Part 1a Only: Area Under the Plasma Concentration Versus Time Curve (AUC) of Comparator Anvumetostat Test Tablet
Part 1k Only: Cmax of Anvumetostat during fasted state
Part 1k Only: Tmax of Anvumetostat during fasted state
Part 1k Only: AUC of Anvumetostat during fasted state
Part 1k Only: Cmax of Anvumetostat during fed state
Part 1k Only: Tmax of Anvumetostat during fed state
Part 1k Only: AUC of Anvumetostat during fed state

Arms and interventions

Part 1a, Phase 1: Anvumetostat Monotherapy Dose ExplorationExperimental

Participants with MTAP-null solid tumors will receive escalating doses of Anvumetostat to estimate the MTD and/or the RP2D.

Part 1c, Phase 1: Anvumetostat Monotherapy Dose ExpansionExperimental

Participants will receive the identified MTD/RP2D of Anvumetostat in the following cohort: MTAP-null NSCLC.

Part 2a, Phase 1: Anvumetostat Dose Exploration + DocetaxelExperimental

Participants with MTAP-null NSCLC will receive escalating doses of Anvumetostat + a fixed dose of docetaxel to estimate the MTD/RP2D of the combination.

Part 2b, Phase 1: Anvumetostat + Docetaxel Dose ExpansionExperimental

Participants with MTAP-null NSCLC will receive the identified MTD/RP2D of Anvumetostat + docetaxel.

Part 3: Anvumetostat Phase 2Experimental

Participants with MTAP-null solid tumors will receive Anvumetostat.

Part 1e, Phase 1: Anvumetostat Monotherapy Dose ExpansionExperimental

Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null BTC.

Part 1f, Phase 1: Anvumetostat Monotherapy Dose ExpansionExperimental

Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null head and neck squamous cell carcinoma (HNSCC).

Part 1g, Phase 1: Anvumetostat Monotherapy Dose ExpansionExperimental

Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null pancreatic adenocarcinoma.

Part 1h, Phase 1: Anvumetostat Monotherapy Dose ExpansionExperimental

Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null or lost MTAP expression solid tumors (other than lymphoma or primary brain tumor).

Part 1i, Phase 1: Anvumetostat Dose OptimizationExperimental

Participants will receive a randomized dose optimization evaluation of Anvumetostat.

Part 1j, Phase 1: Anvumetostat DSPS Substudy (US Sites Only)Experimental

Participants will receive doses of Anvumetostat and comparator Anvumetostat test tables at different times in a fasted state.

Part 1k, Phase 1: Anvumetostat Food Effect Substudy (US Sites Only)Experimental

Participants will receive Anvumetostat once on a fasted state and once after eating a standardized high-fat, high calorie meal.

Part 1l, Phase 1: Anvumetostat Monotherapy Dose ExpansionExperimental

Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null esophageal/gastric cancer.

Part 1m, Phase 1: Anvumetostat Monotherapy Dose ExpansionExperimental

Participants will receive the identified selected dose/MTD of Anvumetostat in the following cohort: MTAP-null glioma.

Drugs: Anvumetostat, Docetaxel, Comparator Anvumetostat Test Tablet

Sites

75 sites in 14 countries

United States 30, Belgium 5, China 5, Switzerland 5, France 4, Germany 4, South Korea 4, Taiwan 4, Australia 3, Japan 3, Austria 2, Canada 2, Hong Kong 2, United Kingdom 2