NCT05898399 · Artios Pharma Ltd
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients
What this study is about
This interventional study will evaluate the safety, tolerability, how the drug moves through the body, and preliminary effectiveness of ART6043 as treatment given alone or in combination with Olaparib or Niraparib.
View original scientific description
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with Olaparib or Niraparib.
Interventions
DRUG
ART6043
ART6043 will be given orally.
DRUG
Olaparib
Olaparib will be given orally.
Primary outcome measures
Part A: Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)
Severity of adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Part B2: Progression free survival (PFS)
Time frame: Until disease progression (Upto 3.7 years).
PFS is defined as the time from randomization until objective disease progression as defined by Response evaluation criteria in solid tumors (RECIST) v1.1 or death by any cause in the absence of progression, regardless of whether the patient withdraws from study medication or receives another anti-cancer therapy prior to progression.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Have adequate organ function.
- Patients of childbearing potential and patients with partners of childbearing potential are required to use highly effective contraception.
- Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator. Inclusion Criteria specific to Part A1 (ART6043 as Mon
Where
- Grand Rapids, Michigan
- New York, New York
- Oklahoma City, Oklahoma
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Dallas, Texas
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations