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NCT04657068 · ClinicalTrials.gov record · last posted 2026-07-30

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

StatusRecruiting
PhasePhase 1/2
Started2021-01-27
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from the ClinicalTrials.gov record
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

Protocol amendment history 4 changes detected by DataLookout

2026-07-31
Enrollment increased: 442 → 542 participants
2026-07-31
Trial sites expanded: 79 → 82 locations
2026-07-31
Primary completion pushed: 2026-12 → 2028-01
2026-07-31
Completion pushed: 2027-12 → 2028-06
Trial Details
NCT Number NCT04657068
Lead Sponsor Artios Pharma Ltd
Conditions Advanced Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Endometrial Cancer, Metastatic Colorectal Cancer, Pancreatic Ductal Adenocarcinoma +1 more
Enrollment 542 participants
Start Date 2021-01-27
Primary Completion 2028-01 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-30