Study of ART6043 in Advanced/Metastatic Solid Tumors Patients

• Status: Not yet recruiting
• Trial end date: 2026-12-14
• Target enrollment: 0
• Participant gender: All

Summary

This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with Olaparib or Talazoparib.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Artios Pharma Ltd
• Treatments: Olaparib; Talazoparib

Criteria

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 longer. Endocrine and hormonal therapies for the treatment of cancer must have been discontinued 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.

• Radiologically evaluable and measurable and/or non-measurable (prostate cancer patients only) disease.

Inclusion Criteria specific to Part A1 (ART6043 as Monotherapy)

• Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes.

Inclusion criteria specific to Part A2/A3 (ART6043 in combination with Olaparib/Talazoparib)

• Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes.

• 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 a PARPi or a PARPi alone)

• Histologically or cytologically confirmed HER2-ve locally advanced or metastatic carcinoma of the breast.

• Documentation of a deleterious or suspected deleterious g/sBRCA mutation.

• No more than 3 prior chemotherapy-inclusive schedules (including antibody conjugates) for locally advanced and/or metastatic disease.

• 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.

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 aabsorption of ART6043, Talazoparib or Olaparib.

• Patients with brain metastases (patients with treated brain metastases could be eligible if follow-up brain imaging after central nervous system-directed therapy shows no evidence of progression).

• 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

• First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy.

• Inflammatory breast cancer.