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)
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
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.
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