Clinical Trials in the UK / NCT05898399
Recruiting
Phase 1/2
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
NCT05898399 · tracked via the Priya Life Science UK tracker
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
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)
- Part A: Number of participants with Dose Limiting Toxicities (DLTs) — From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)
Severity of adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0. - Part B2: Progression free survival (PFS) — Until disease progression (Upto 3.7 years).
PFS is defined as the time from randomization until objective disease progression as defined by Response evaluation criteria in solid tumors (RECIST) v1.1 or death by any cause in the absence of progression, regardless of whether the patient withdraws from study medication or receives another anti-cancer therapy prior to progression.
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
On this site
📄 Lynparza (olaparib) drug profile →More Artios Pharma Ltd trials in the UK
Other trials for the same condition
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 UK