NCT04657068

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

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: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 442 (estimated)
• Sponsor: Artios Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

ART0380 is a new investigational medicinal product that is a potent and selective inhibitor of Ataxia telangiectasia and Rad3-related (ATR). ART0380 is being developed as an oral anti-cancer agent for the treatment of participants with cancers that harbor defects in deoxyribonucleic acid (DNA) repair and in combination with agents including those that cause DNA damage. This study is an open-label Phase I/IIa study designed to evaluate the safety, tolerability, PK and preliminary efficacy of ART0380 as monotherapy or in combination with gemcitabine or irinotecan in participants with advanced or metastatic solid tumors, advanced or solid tumors that fail to express Ataxia-Telangiectasia Mutated protein kinase (ATM), and high grade serous ovarian, primary peritoneal or fallopian tube carcinoma.

Conditions

• Advanced Cancer
• Metastatic Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer
• Fallopian Tube Cancer
• Endometrial Cancer
• Metastatic Colorectal Cancer
• Pancreatic Ductal Adenocarcinoma
• Acinar Cell Carcinoma

Interventions

Type	Name	Description
DRUG	ART0380	Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.
DRUG	Gemcitabine	Gemcitabine will be administered on Days 1 and 8 of a 21-day cycle.
DRUG	Irinotecan	Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.

Timeline

• Start date: 2021-01-27
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2020-12-08
• Last updated: 2026-03-18

Locations

79 sites across 4 countries: United States, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study