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
Artios Pharma Ltd
Summary
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
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: 1. Part A (Dose-escalation phase): Part A will evaluate ART6043 as monotherapy (Part A1) in patients with advanced or metastatic cancer and in combination with olaparib (Part A2), in patients with advanced or metastatic cancer with genetic lesions that cause loss of function of known DNA Damage Response (DDR) genes. Olaparib is also referred as PARP…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients who have discontinued all previous chemotherapeutic agents, non-hormonal targeted therapy, or investigational drugs for at least 21 days or 5 half-lives (not including palliative radiotherapy at focal sites), whichever is shorter. Endocrine and hormonal therapies for the treatment of cancer must have been discontinued (unless for the treatment of Prostate Cancer) at least 7 days before receiving study medication. Palliative radiotherapy must have completed prior to start of study treatment. * Resolution of all toxicities of prior therapy or surgical procedures.…
Interventions
- DrugART6043
ART6043 will be given orally.
- DrugOlaparib
Olaparib will be given orally.
Locations (12)
- South Texas Accelerated Research Therapeutics (START) - MidwestGrand Rapids, Michigan
- Memorial Sloan-Kettering Cancer Center (MSKCC)New York, New York
- Stephenson Cancer Center - OncologyOklahoma City, Oklahoma
- Jefferson University Hospitals - Kimmel Cancer CenterPhiladelphia, Pennsylvania
- SCRI oncology partnersNashville, Tennessee
- Mary Crowley Cancer Center - ClinicDallas, Texas