Study of ART4215 as Monotherapy & in Combination to Patients with Advanced/Metastatic Solid Tumours
Research type
Research Study
Full title
A Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART4215 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumours
IRAS ID
1004044
Contact name
Ian Smith
Contact email
Sponsor organisation
Artios Pharma Limited
Eudract number
2021-002574-69
Clinicaltrials.gov Identifier
Research summary
This is a study to investigate the safety and tolerability of the study drug, ART4215, in patients with advanced cancer. ART4215 is a new drug called a DNA-polymerase theta-inhibitor that causes damage to DNA in cancer cells preventing them from dividing and multiplying. ART4215 is experimental and not yet approved by any regulatory bodies. Patients will receive ART4215 on its own daily or in combination with talazoparib daily. Talazoparib has been approved in the UK, US and Europe, but has not been approved in combination with ART4215.
Some participants receiving ART4215 alone will be given the first 2 doses of ART4215 with and without food before continuing with ART4215 in a fasted condition. Some other participants in will also receive 2 doses of the drug olaparib before continuing with ART4215 on its own. The study treatment is split into cycles of 21 days each. During each cycle you will attend the hospital for assessments including physical examinations, ECGs, ECHO, blood and urine samples, and for some patients tissue samples.REC name
London - Harrow Research Ethics Committee
REC reference
21/LO/0817
Date of REC Opinion
12 Jan 2022
REC opinion
Further Information Favourable Opinion