Evaluating ART6043 for patients with advanced metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043, an oral anti-cancer agent, either alone or in combination with PARP inhibitors Olaparib or Niraparib. The study is divided into two parts: a dose-escalation phase to evaluate ART6043 as monotherapy and in combination with PARPi, and a dose-expansion phase to confirm safety and assess initial effectiveness in specific breast cancer types. Patients may continue treatment as long as they benefit clinically or until disease progression or unacceptable toxicity occurs.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Clínico San Cecilio
  Granada, Andalusia, Spain Recruiting
• Hospital Clínico Universitario de Valladolid
  Valladolid, Castille and León, Spain Recruiting
• Hospital de la Santa Creu i Sant Pau
  Barcelona, Catalonia, Spain Recruiting
• Hospital San Pedro de Alcántara
  Cáceres, Extremadura, Spain Recruiting
• Hospital Universitario 12 de Octubre
  Madrid, Madrid, Spain Recruiting
• Hospital Clinico San Carlos
  San Carlos, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Artios Pharma
• Email: info@artios.com
• Phone: +44 (0)1223 867 900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.