RecruitingAdvanced Solid TumorMetastatic Solid Tumor
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
Sponsor: Artios Pharma Ltd
You may qualify if…
- ✓ 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.
- ✓ Advanced or metastatic cancer. Tumors with genetic lesions known to cause loss of function of known DDR genes based on available pre-existing testing are encouraged.
- ✓ Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes based on available, pre-existing testing.
You may not qualify if…
- ✕ Patients who are pregnant.
- ✕ Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- ✕ Have ongoing interstitial lung disease or pneumonitis.
- ✕ Have any major gastrointestinal issues that could impact absorption of ART6043 or olaparib.
- ✕ Patients with brain metastases (patients with treated brain metastases could be eligible if follow-up brain imaging after central nervous system-directed therapy shows no evidence of progression).
- ✕ Have received a live vaccine within 30 days before the first dose of study treatment.
- ✕ Recent major surgery within 4 weeks prior to entry into the study.
- ✕ Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05898399 · last updated 2026-05-01