A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

Study acronym: ARC-27
StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed
    • Final enrollment: 29 participants (planned 91)
    • Primary completion date changed from estimate of Nov 2026 to Apr 29, 2026
    • Eligibility criteria expanded, about 12 words
  2. 3 versions Re-verified since May 29, 2026, no change to tracked fieldsv30-v32
  3. Study sites revised (10)v29
  4. 3 versions Re-verified since Feb 5, 2026, no change to tracked fieldsv26-v28
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v25
Show 23 earlier versionsHide 23 earlier versions
  1. 3 versions Re-verified since Sep 30, 2025, no change to tracked fieldsv22-v24
  2. Study sites: 9 to 10v21
  3. Study sites: 10 to 9v20
  4. Study sites: 7 to 10v19
  5. Study sites: 10 to 7v18
  6. Study sites: 11 to 10v17
  7. Study sites: 10 to 11v16
  8. Study sites revised (10)v15
  9. Study sites revised (10)v14
  10. Enrollment target: 80 to 91
    • Interventions: AB801 (Drug), Docetaxel (Drug), Zimberelimab (Drug) to AB801 (Drug), Docetaxel (Drug)
    • Eligibility criteria shortened, about 99 words
    v13
  11. 2 versions Re-verified since Dec 18, 2024, no change to tracked fieldsv11-v12
  12. Study sites revised (10)v10
  13. Study sites: 7 to 10v9
  14. Study sites: 6 to 7v8
  15. Re-verified, no change to tracked fieldsv7
  16. Study sites: 5 to 6v6
  17. Study sites: 4 to 5v5
  18. Study sites: 1 to 4v4
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2024 to Jan 19, 2024
    v3
  20. Start date: Dec 1, 2023 to Jan 2024v2
  1. Study First Submitted
  • 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.
The primary purpose of this study is to assess the safety and tolerability of AB801 in participants with advanced malignancies, and to determine a recommended AB801 dose for expansion.
Trial Details
NCT Number NCT06120075
Lead Sponsor Arcus Biosciences, Inc.
Conditions
(from sponsor)		 Advanced Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov