Study of ART6043 in Advanced/Metastatic Solid Tumors Patients
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 DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors
IRAS ID
1009916
Contact name
Ian Smith
Contact email
Sponsor organisation
Artios Pharma Limited
Clinicaltrials.gov Identifier
Research summary
The main purpose of the study is to see if a new experimental study drug called ART6043 that has not yet been approved by regulatory authorities is safe and effective both on its own and in combination with either olaparib or niraparib. This is the first study in which ART6043 is being given to humans. The UK is participating in Part B of the study, which will recruit patients with advanced or metastatic breast cancer.
Current treatments for cancer include surgery, chemotherapy, radiotherapy and targeted therapy.
ART6043 is a type of drug known as a DNA polymerase theta (DNA Polθ) inhibitor, which prevents a protein called DNA Polθ from working. The DNA Polθ protein helps repair damage to the genetic code (DNA). This process that repairs the genetic code is called the DNA damage response (DDR).
Many types of tumours produce more than a normal amount of DNA Polθ protein and cancer cells often have several abnormalities in their DDR. If drugs such as ART6043 can cause the DDR to stop working, then the cancer cells will die.
Olaparib and niraparib are approved cancer drugs known as PARP inhibitors, which may keep cancer cells from repairing their damaged DNA.
ART6043 is taken orally as tablets.
This study is open label, which means participants, the study doctor and the Sponsor will know what treatment(s) the participants are taking.
This study consists of 2 parts: Part A (dose escalation phase) and Part B (dose expansion phase).
Up to approximately 120 participants are expected to take part in the US and Europe in Part A, and up to approximately 120 participants are expected to take part in the US, UK, and Europe in Part B.The Sponsor is Artios Pharma Limited based in the UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0783
Date of REC Opinion
12 Nov 2024
REC opinion
Further Information Favourable Opinion