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: 13 Jun 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

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.
08 Jun 2025 Planned primary completion date changed from 1 Jun 2025 to 1 Dec 2026.

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