Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtios Pharma Ltd
About this trial
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ART6043
- Olaparib
Treatment groups
181 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov