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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: 05 Dec 2025

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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

  • 17 Nov 2025 According to Artios Pharma media release, The Series D proceeds will expand the clinical evaluation of Artios' lead program, alnodesertib, to enroll additional ATM negative1 patients in each of second line pancreatic cancer and third line colorectal cancer.
  • 24 Sep 2025 According to Artios Pharma media release, U.S. Food and Drug Administration (FDA) granted Fast Track designation to alnodesertib based on the data from the trial.
  • 12 Aug 2025 According to Artios Pharma media release, Alnodesertib ORR data from STELLA Phase 2 expansion cohorts expected in 2026.

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