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A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

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Trial Profile

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Mar 2026

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At a glance

  • Drugs Alnodesertib (Primary) ; Gemcitabine (Primary) ; Irinotecan (Primary)
  • Indications Adenocarcinoma; Anal cancer; Carcinoma; Cholangiocarcinoma; Colorectal cancer; Endometrial cancer; Fallopian tube cancer; Ovarian cancer; Pancreatic ductal carcinoma; Peritoneal cancer; Solid tumours
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Acronyms STELLA
  • Sponsors Artios Pharma

Most Recent Events

  • 02 Mar 2026 According to Artios Pharma Media Release, data from the trial were presented at Clinica Universidad de Navarra, in a poster session at the 27th European Society of Gynaecological Oncology (ESGO) Annual Meeting held in Copenhagen, Denmark, from February 26-28, 2026.
  • 02 Mar 2026 According to Artios Pharma Media Release, primary endpoint (Part B2: Progression free survival by RECIST 1.1 in participants receiving ART0380 in combination with gemcitabine or gemcitabine alone) has been met.
  • 02 Mar 2026 Results presented in the Artios Pharma Media Release

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