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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: 09 Oct 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

  • 12 Aug 2025 According to Artios Pharma media release, Alnodesertib ORR data from STELLA Phase 2 expansion cohorts expected in 2026.
  • 08 Jun 2025 Planned number of patients changed from 547 to 597.
  • 08 Jun 2025 Planned End Date changed from 1 Jun 2025 to 1 Dec 2026.

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