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

Inclusion Criteria14

• 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 prior to start of study treatment.
• 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.
• 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.
• 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.
• 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.
• Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated.
• Patients must have received no or ≤1 month of prior treatment with a PARPi.