Spots Global Cancer Trial Database for Study of ART6043 in Advanced/Metastatic Solid Tumors Patients

Study Description

Brief Summary: This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with Olaparib or Niraparib.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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