Clinical Trial

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

MOA: ART0380 selectively targets and inhibits ATR activity and blocks the downstream phosphorylation of the serine/threonine protein kinase CHK1.

Key Eligibility Criteria:

• Patients with BRCA mutations or HRD-positive cancer should
  receive an approved PARPi treatment if available
• At least 1 lesion that can be radiologically evaluated by RECIST v1.1
• Patients who are known to be homozygous for the UGT1A1 *6 or *28
  or simultaneously heterozygous for the UGT1A1 *6 and *28 are
  excluded
• Sufficient non-irradiated tumor tissue sample available for analysis
• Cohort B1: Advanced or metastatic solid tumor with complete loss
  of ATM protein (IHC H score 0)
• Cohort B5: Metastatic CRC with complete loss of ATM protein (IHC
  H score 0)
• Patients should have previously received and failed treatment
  with fluoropyrimidine-, oxaliplatin-based chemotherapy