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A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 2026 → Jan 2028
See other at-risk trials from Artios Pharma Ltd

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Jan 2028v23 Show 4 more changesShow less
    • Enrollment increased: 442 → 542 participants
    • Trial sites expanded: 79 → 82 locations
    • Study completion pushed from Dec 2027 to Jun 2028
    • Eligibility criteria expanded, about 109 words
  2. Start date: Dec 13, 2020 to Jan 27, 2021v22 Show 8 more changesShow less
    • Primary endpoints revised (4)
    • Enrollment target: 502 to 442
    • Study sites: 75 to 79
    • Study completion date: Dec 2026 to Dec 2027
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 20 to 33
    • Study arms: 11 to 10
    • Study description shortened, about 2 words
  3. Study sites: 71 to 75v21
  4. Primary endpoints: 3 to 4v20 Show 5 more changesShow less
    • Enrollment target: 597 to 502
    • Study sites: 66 to 71
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: 26 to 20
    • Study arms: 9 to 11
  5. Primary and study completion dates: Jun 2025 to Dec 2026v19 Show 6 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 547 to 597
    • Study sites: 43 to 66
    • Eligibility criteria expanded, about 118 words
    • Secondary endpoints: 9 to 26
    • Study arms: 8 to 9
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 40 to 43
    • Eligibility criteria expanded, about 9 words
    v18
  2. Primary endpoints revised (3)v17 Show 5 more changesShow less
    • Enrollment target: 462 to 547
    • Study sites: 34 to 40
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: 8 to 9
    • Study arms: 7 to 8
  3. Primary endpoints revised (3)
    • Enrollment target: 372 to 462
    • Study sites: 32 to 34
    • Eligibility criteria shortened, about 1 word
    v16
  4. Enrollment target: 242 to 372v15 Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Study sites: 28 to 32
    • Eligibility criteria expanded, about 100 words
    • Secondary endpoints revised (8)
    • Study arms: 5 to 7
  5. Eligibility criteria expanded, about 13 wordsv14
  6. Study sites: 11 to 28v13
  7. Primary and study completion dates: Dec 2023 to Jun 2025v12 Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Enrollment target: 232 to 242
    • Start date: Jan 13, 2021 to Dec 13, 2020
    • Eligibility criteria expanded, about 64 words
    • Site contacts updated at 1 of 11 sites
  8. Study sites: 10 to 11v11
  9. Study sites: 7 to 10v10
  10. Study sites: 6 to 7v9
  11. Primary endpoints revised (3)v8 Show 7 more changesShow less
    • Enrollment target: 180 to 232
    • Study sites: 5 to 6
    • Interventions: ART0380 (Drug), Gemcitabine (Drug) to ART0380 (Drug), Gemcitabine (Drug), Irinotecan (Drug)
    • Eligibility criteria expanded, about 197 words
    • Secondary endpoints revised (8)
    • Study arms: 4 to 5
    • Study description expanded, about 2 words
  12. Study sites: 3 to 5v7
  13. Secondary endpoints revised (8)
    • Site details revised at 1 of 3 sites
    v6
  14. Eligibility criteria shortened, about 2 wordsv5
  15. Re-verified, no change to tracked fieldsv4
  16. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Dec 2020 to Jan 13, 2021
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: 31 to 8
    • Site details revised at 3 of 3 sites
  17. Secondary endpoints revised (31)v2
  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.
Artios Pharma Ltd
3 trials monitored
See 1 trial at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Pancreatic Cancer
1,739 trials monitored
See 106 trials at risk
Ovarian Cancer
1,336 trials monitored
See 90 trials at risk
and 1 more disease
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
Trial Details
NCT Number NCT04657068
Lead Sponsor Artios Pharma Ltd
Conditions
(from sponsor)		 Advanced Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Endometrial Cancer, Metastatic Colorectal Cancer, Pancreatic Ductal Adenocarcinoma +1 more
Related terms Carcinoma, Acinar Cell, Colorectal Neoplasms, Endometrial Neoplasms, Fallopian Tube Neoplasms, Hereditary Sensory and Autonomic Neuropathies, Neoplasm Metastasis, Ovarian Neoplasms
Enrollment 542 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov