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New treatment option for Advanced Solid Tumor
Official title Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
ClinicalTrials.gov ID: NCT05898399
What this study is testing
What is ART6043?
ART6043 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who have discontinued all previous chemotherapeutic agents, non-hormonal targeted therapy, or investigational drugs for at least 21 days or...
- 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.
You likely can't join 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...
- Have received a live vaccine within 30 days before the first dose of study treatment.
See the full eligibility 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)...
- 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. specific to Part A1 (ART6043 as Monotherapy)
- 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. specific to Part A2 (ART6043 in combination with...
- Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes based on available, pre-existing testing.
- Patients for whom a PARPi is an appropriate treatment option. Patients may have received prior treatment with a PARPi. specific to Part B (ART6043 in combination with olaparib or olaparib alone)
- Histologically or cytologically confirmed HER2-ve locally advanced or metastatic carcinoma of the breast.
- Documentation of a deleterious or suspected deleterious gBRCA mutation.
- Previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting unless medically contraindicated.
- Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated.
- Patients must have received no or ≤1 month of prior treatment with a PARPi.
- 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.
- Have a history of allergy or hypersensitivity to study drug components. Exclusion criteria specific to Part B
- First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy.
- Inflammatory breast cancer.
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Granada, Andalusia, Spain
- Valladolid, Castille and León, Spain
- Barcelona, Catalonia, Spain
- Cáceres, Extremadura, Spain
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States; New York, New York, United States; Oklahoma City, Oklahoma, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Dallas, Texas, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.