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Clinical Trials in the USA / NCT05898399
Recruiting Phase 1/Phase 2

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

NCT05898399 · tracked via the Priya Life Science USA tracker
Sponsor
Artios Pharma Ltd
Phase
Phase 1/Phase 2
Started
2023-06-30
Last updated
2026-09-15

Condition(s) studied

Advanced Solid TumorMetastatic Solid Tumor

Investigational drug(s) / intervention(s)

ART6043Olaparib

ART6043: ART6043 will be given orally.

Olaparib: Olaparib will be given orally.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
South Texas Accelerated Research Therapeutics (START) - Midwest Grand Rapids Michigan Active Not Recruiting
Memorial Sloan-Kettering Cancer Center (MSKCC) New York New York Active Not Recruiting
Stephenson Cancer Center - Oncology Oklahoma City Oklahoma Active Not Recruiting
Jefferson University Hospitals - Kimmel Cancer Center Philadelphia Pennsylvania Active Not Recruiting
SCRI oncology partners Nashville Tennessee Completed
Mary Crowley Cancer Center - Clinic Dallas Texas Completed
The University of Texas - MD Anderson Cancer Center Houston Texas Active Not Recruiting
Hospital Universitario Clínico San Cecilio Granada Andalusia Recruiting
Hospital Clínico Universitario de Valladolid Valladolid Castille and León Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Catalonia Recruiting
Hospital San Pedro de Alcántara Cáceres Extremadura Recruiting
Hospital Clinico San Carlos San Carlos Madrid Recruiting
Hospital Universitario de Jerez de la Frontera Cadiz Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Clinico Universitario Virgen de la Arrixaca Murcia Spain Recruiting
Hospital Universitario Virgen del Rocio Seville Spain Recruiting
Hospital Clinico Universitario de Valencia Valencia Spain Recruiting
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05898399 on ClinicalTrials.gov ↗ ← All trials in the USA