Actively Recruiting
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
Led by Artios Pharma Ltd · Updated on 2026-05-01
181
Participants Needed
12
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
CONDITIONS
Official Title
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have stopped all previous chemotherapy, non-hormonal targeted therapy, or investigational drugs for at least 21 days or 5 half-lives, except palliative radiotherapy which must be completed before study treatment.
- Endocrine and hormonal therapies must be stopped at least 7 days before study medication, except for prostate cancer treatment.
- All toxicities from prior treatments or surgeries must be resolved.
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale.
- Adequate organ function is required.
- Patients of childbearing potential and their partners must use highly effective contraception.
- Estimated life expectancy of at least 12 weeks as judged by the investigator.
- For Part A1: Advanced or metastatic cancer; tumors with genetic lesions causing loss of function of known DNA damage response (DDR) genes are encouraged.
- For Part A2: Advanced or metastatic cancer with genetic lesions causing loss of function of DDR genes; patients eligible for PARP inhibitor treatment and may have prior PARP inhibitor therapy.
- For Part B: Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer.
- Documented deleterious or suspected deleterious germline BRCA mutation.
- Prior chemotherapy in neoadjuvant, adjuvant, or metastatic setting unless medically contraindicated.
- Prior taxane treatment in neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated.
- No more than one month of prior PARP inhibitor treatment.
You will not qualify if you...
- Pregnant patients.
- Patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or features suggesting these conditions.
- Ongoing interstitial lung disease or pneumonitis.
- Major gastrointestinal problems affecting absorption of ART6043 or olaparib.
- Patients with brain metastases, unless treated and stable with no progression on follow-up imaging.
- Receipt of live vaccine within 30 days before first dose of study treatment.
- Major surgery within 4 weeks before study entry.
- Significant bleeding disorders or vasculitis, or grade 3 or higher bleeding episode within 12 weeks before enrollment.
- History of allergy or hypersensitivity to study drug components.
- For Part B: First-line locally advanced or metastatic breast cancer with no prior adjuvant chemotherapy.
- Inflammatory breast cancer.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
South Texas Accelerated Research Therapeutics (START) - Midwest
Grand Rapids, Michigan, United States, 49546
Active, Not Recruiting
2
Memorial Sloan-Kettering Cancer Center (MSKCC)
New York, New York, United States, 10065-6800
Active, Not Recruiting
3
Stephenson Cancer Center - Oncology
Oklahoma City, Oklahoma, United States, 73104
Active, Not Recruiting
4
Jefferson University Hospitals - Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 17107
Active, Not Recruiting
5
SCRI oncology partners
Nashville, Tennessee, United States, 37203
Completed
6
Mary Crowley Cancer Center - Clinic
Dallas, Texas, United States, 75251
Completed
7
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
8
Hospital Universitario Clínico San Cecilio
Granada, Andalusia, Spain, 18007
Actively Recruiting
9
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, Spain, 47003
Actively Recruiting
10
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08025
Actively Recruiting
11
Hospital San Pedro de Alcántara
Cáceres, Extremadura, Spain, 10003
Actively Recruiting
12
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
Research Team
A
Artios Pharma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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