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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA) (NCT05898399) is a Phase 1 / Phase 2 interventional studying Advanced Solid Tumor and Metastatic Solid Tumor, sponsored by Artios Pharma Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Solid Tumor, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 181 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Solid Tumor subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 your organs (liver, kidneys, etc.) are working well enough based on blood tests. - 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) - diagnosed by tissue sample (biopsy-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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 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. * 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. 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. * 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.

Treatments Being Tested

DRUG

ART6043

ART6043 will be given orally.

DRUG

Olaparib

Olaparib will be given orally.

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

South Texas Accelerated Research Therapeutics (START) - Midwest
Grand Rapids, Michigan, United States
Memorial Sloan-Kettering Cancer Center (MSKCC)
New York, New York, United States
Stephenson Cancer Center - Oncology
Oklahoma City, Oklahoma, United States
Jefferson University Hospitals - Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
SCRI oncology partners
Nashville, Tennessee, United States
Mary Crowley Cancer Center - Clinic
Dallas, Texas, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Hospital Universitario Clínico San Cecilio
Granada, Andalusia, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital San Pedro de Alcántara
Cáceres, Extremadura, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05898399), the sponsor (Artios Pharma Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05898399 clinical trial studying?

This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05898399?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05898399?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05898399. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05898399. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.