Advanced Solid Tumor Clinical Trial
Official 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
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with Olaparib or Niraparib.
ART6043 is being developed as an oral anti-cancer agent in combination with a poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor (PARPi) in patients with cancers that harbor defects in DNA repair. The study will consist of two parts: Part A (dose-escalation phase) & Part B (dose-expansion phase). Part A will evaluate ART6043 as monotherapy (Part A1) in patients with advanced or metastatic cancer and in combination with either Olaparib (Part A2) or Niraparib (Part A3), in patients with advanced or metastatic cancer with genetic lesions that cause loss of function of known DNA Damage Response (DDR) genes. Olaparib or Niraparib are collectively referred to as PARPi. Part B will evaluate the preliminary efficacy, safety profile, and PK of ART6043 in combination with a PARPi compared to PARPi alone. Part B will randomize patients with human epidermal growth factor receptor 2 negative (HER2-ve) locally advanced or metastatic breast cancer with a germline or somatic breast cancer gene (BRCA) mutation (g/sBRCA-m) who have received no or ≤1 month of prior treatment with a PARPi, in a 1:1 to an RP2D of ART6043 in combination with a PARPi vs a PARPi alone. Patients may continue to receive ART6043 and/or PARPi as long as they may be continuing to derive clinical benefit as assessed by the investigator and/or until disease progression, withdrawal of consent or until they experience unacceptable drug-related toxicity. ;
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