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RecruitingPhase 1 / Phase 2

Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ART6043 alone or with olaparib in people with solid tumors that are advanced or have spread. It looks at safety, side effects, how the body handles the drug, and early signs that it works. One part is for people with a certain type of breast cancer and compares the drug combination with olaparib alone.

This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Stop prior chemotherapy, non-hormone targeted drugs, or study drugs for 21 days or 5 drug half-lives, whichever is shorter. A half-life is the time for the body to clear half a drug. Stop cancer hormone therapy at least 7 days before study treatment, except for prostate cancer treatment. Finish radiation for symptom relief at least 14 days before treatment assignment.
  • Side effects from past treatment or surgery must have cleared, and organs must work well enough.
  • Have an ECOG activity score of 0–2: able to care for yourself and be up and about for at least half the day.
  • Use highly effective birth control if you or your partner could become pregnant. The study doctor must expect you to live at least 12 weeks.
  • Part A1, ART6043 alone: have advanced cancer or cancer that has spread. People whose past tests show changes that stop DNA-repair genes from working are encouraged to join.
  • Part A2, ART6043 with olaparib: have advanced cancer or cancer that has spread, with past tests showing changes that stop DNA-repair genes from working. A PARP inhibitor, a type of cancer drug, must be a suitable treatment. Past use is allowed.
  • Part B: have breast cancer that has grown nearby or spread, confirmed by tissue or cell testing. It must be HER2-negative, meaning it does not have high levels of the HER2 protein. Tests must show an inherited BRCA gene change known or suspected to be harmful.
  • Part B: have had chemotherapy before or after surgery, or for cancer that has spread, unless it was medically unsafe. Have had no more than 1 month of treatment with a PARP inhibitor.

Who can't join

  • Are pregnant.
  • Have MDS or AML, which are bone marrow or blood cancers, or signs suggesting either condition.
  • Have ongoing lung inflammation, called interstitial lung disease or pneumonitis.
  • Have major stomach or bowel problems that could affect how your body absorbs the study drugs.
  • Had a live vaccine within 30 days before the first study dose, or major surgery within 4 weeks before joining.
  • Have a serious bleeding disorder, inflamed blood vessels, or a severe bleeding episode within 12 weeks before joining.
  • Have had an allergic reaction to any ingredient in the study drugs.
  • Part B: have inflammatory breast cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 14 days prior to randomization. * 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 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. Inclusion criteria specific to Part A2 (ART6043 in combination with olaparib) * 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. Inclusion criteria 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. * Patients must have received no or ≤1 month of prior treatment with a PARPi. Exclusion Criteria: * 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. * 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 • Inflammatory breast cancer.

Study sites (7)

MI

NY

OK

PA

TN

TX