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Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Study acronym: ACTION-1
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Enrollment target: estimated 338 to confirmed 343 · Site details revised at 54 of 54 sites · Publications: details revised at 1 of 1 entry · 1 more Show 4 more changesShow less
    • Enrollment target: estimated 338 to confirmed 343
    • Site details revised at 54 of 54 sites
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 2 words
  2. Enrollment increased: 288 → 338 participants Completion pushed from Jul 2028 to Dec 2030v39 Show 1 more changeShow less
    • Completion pushed from Jul 2028 to Dec 2030
  3. Primary completion date: Dec 2025 to Dec 2026 Study sites: 53 to 54 · Eligibility criteria expanded, about 38 words · Study arms: 3 to 4v38 Show 3 more changesShow less
    • Study sites: 53 to 54
    • Eligibility criteria expanded, about 38 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv37
  5. Study sites: 51 to 53v36
Show 34 earlier versionsHide 34 earlier versions
  1. Study sites: 50 to 51 Primary completion date: Jul 2025 to Dec 2025v35 Show 1 more changeShow less
    • Primary completion date: Jul 2025 to Dec 2025
  2. Eligibility criteria shortened, about 14 words Site details revised at 9 of 50 sitesv34 Show 1 more changeShow less
    • Site details revised at 9 of 50 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Study Status, Eligibilityv33
  4. Trial status: Active, Not Recruiting to Recruiting Study sites: 58 to 50 · Interventions: Everolimus 10 mg (Drug), Lanreotide 120Mg Sa Susp Inj Syringe (Drug), Octreotide LAR 60 MG Injection (Drug), RYZ101 (Drug), Sunitinib 37.5… to Everolimus (Drug), Lanreotide (Drug), Octreotide (Drug), RYZ101 (Drug), Sunitinib (Drug) · Eligibility criteria shortened, about 593 words · 1 morev32 Show 4 more changesShow less
    • Study sites: 58 to 50
    • Interventions: Everolimus 10 mg (Drug), Lanreotide 120Mg Sa Susp Inj Syringe (Drug), Octreotide LAR 60 MG Injection (Drug), RYZ101 (Drug), Sunitinib 37.5… to Everolimus (Drug), Lanreotide (Drug), Octreotide (Drug), RYZ101 (Drug), Sunitinib (Drug)
    • Eligibility criteria shortened, about 593 words
    • Secondary endpoints shortened, about 70 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Recruiting to Active, Not Recruiting Site details revised at 58 of 58 sitesv31 Show 1 more changeShow less
    • Site details revised at 58 of 58 sites
  6. Site details revised at 4 of 58 sitesv30
  7. Site details revised at 1 of 58 sitesv29
  8. Study sites: 57 to 58v28
  9. Study sites: 55 to 57v27
  10. Site details revised at 3 of 55 sitesv26
  11. Site details revised at 2 of 55 sitesv25
  12. Study sites: 51 to 55v24
  13. Study sites: 32 to 51v23
  14. Study sites: 26 to 32v22
  15. Eligibility criteria expanded, about 37 wordsv21 See this version in full on ClinicalTrials.gov ↗
  16. Enrollment target: 218 to 288 Study sites: 25 to 26v20 Show 1 more changeShow less
    • Study sites: 25 to 26
  17. Study sites: 24 to 25v19
  18. Study sites: 23 to 24v18
  19. Study sites: 12 to 23v17
  20. Study sites: 8 to 12v16
  21. Study sites: 7 to 8v15
  22. Eligibility criteria expanded, about 45 words Site details revised at 1 of 7 sitesv14 Show 1 more changeShow less
    • Site details revised at 1 of 7 sites

    See this version in full on ClinicalTrials.gov ↗

  23. Site details revised at 2 of 7 sitesv13
  24. Study title revisedv12 See this version in full on ClinicalTrials.gov ↗
  25. Site details revised at 3 of 7 sitesv11
  26. Phase: Phase 1/2 to Phase 3v10
  27. Trial status: Active, Not Recruiting to Recruiting Site details revised at 7 of 7 sitesv9 Show 1 more changeShow less
    • Site details revised at 7 of 7 sites
  28. Study sites revised (7)v8 See this version in full on ClinicalTrials.gov ↗
  29. Re-verified, no change to tracked fieldsv7
  30. Trial status: Recruiting to Active, Not Recruiting Site details revised at 7 of 7 sitesv6 Show 1 more changeShow less
    • Site details revised at 7 of 7 sites
  31. Study sites: 6 to 7v5
  32. Study sites: 5 to 6v4
  33. Study sites: 4 to 5v3
  34. Site details revised at 4 of 4 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
Trial Details
NCT Number NCT05477576
Lead Sponsor RayzeBio, Inc.
Conditions GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor, Pancreatic NET
Enrollment 343 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov