ART0380 Monotherapy & Combination in Advanced/Metastatic Solid Tumours

• Research type

  Research Study

• Full title

  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

• IRAS ID

  303008

• Contact name

  Elisa Fontana Fontana

• Contact email

  Elisa.Fontana@HCAHealthcare.co.uk

• Sponsor organisation

  Artios Pharma Limited

• Eudract number

  2021-003472-14

• Clinicaltrials.gov Identifier

  NCT04657068

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  4 years, 11 months, 30 days

• Research summary

  This is a Phase I/IIa, Open-label, Multi-center Two-Part Study Assessing the Safety and Efficacy of ART0380 as Oral Therapy in Patients with an Advanced or Metastatic Solid Tumor.

  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 in combination with irinotecan.
  Learn more about the side effects of ART0380 alone and in combination with gemcitabine or in combination with irinotecan.
  Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or in combination with irinotecan.

• REC name

  Wales REC 1

• REC reference

  21/WA/0275

• Date of REC Opinion

  13 Oct 2021

• REC opinion

  Further Information Favourable Opinion