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Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 8 months later Jul 16, 2027 → Mar 16, 2029
See other at-risk trials from AstraZeneca

Record History

  1. Primary and study completion pushed from Jul 16, 2027 to Mar 16, 2029 Enrollment increased: 280 → 392 participants · Interventions modified · Trial arms changed: 2 → 3 · 4 more Show 7 more changesShow less
    • Enrollment increased: 280 → 392 participants
    • Interventions modified
    • Trial arms changed: 2 → 3
    • Eligibility criteria expanded, about 87 words
    • Secondary endpoints: details revised at 6 of 11 entries
    • Study description expanded, about 8 words
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv22
  3. Primary and study completion dates: Jun 15, 2027 to Jul 16, 2027v21
  4. Primary and study completion dates: Dec 16, 2026 to Jun 15, 2027 Enrollment target: 240 to 280 · Eligibility criteria expanded, about 11 wordsv20 Show 2 more changesShow less
    • Enrollment target: 240 to 280
    • Eligibility criteria expanded, about 11 words

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Apr 15, 2025, no change to tracked fieldsv18-v19
Show 16 earlier versionsHide 16 earlier versions
  1. Site details revised at 1 of 25 sitesv17
  2. Enrollment target: 200 to 240 Primary and study completion dates: Dec 11, 2026 to Dec 16, 2026 · Site details revised at 2 of 25 sitesv16 Show 2 more changesShow less
    • Primary and study completion dates: Dec 11, 2026 to Dec 16, 2026
    • Site details revised at 2 of 25 sites
  3. Site details revised at 3 of 25 sitesv15
  4. Site details revised at 1 of 25 sitesv14
  5. Study sites: 23 to 25v13
  6. Re-verified, no change to tracked fieldsv12
  7. Site details revised at 1 of 23 sitesv11
  8. Site details revised at 1 of 23 sitesv10
  9. Site details revised at 1 of 23 sitesv9
  10. Study sites: 22 to 23v8
  11. 2 versions Re-verified since Feb 14, 2024, no change to tracked fieldsv6-v7
  12. Study sites: 19 to 22v5
  13. Study sites: 22 to 19 Eligibility criteria expanded, about 15 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  14. Site details revised at 3 of 22 sitesv3
  15. Study sites: 17 to 22v2
  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.
AstraZeneca
727 trials monitored
See 61 trials at risk
Pancreatic Cancer
1,639 trials monitored
See 91 trials at risk
Gastric Cancer
1,201 trials monitored
See 59 trials at risk
Esophageal Cancer
1,012 trials monitored
See 53 trials at risk
This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.
Trial Details
NCT Number NCT06005493
Lead Sponsor AstraZeneca
Conditions Gastric Cancer, Gastro-esophageal Junction Cancer, Pancreatic Ductal Adenocarcinoma, Esophageal Adenocarcinoma
Enrollment 392 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov