ACTIVE_NOT_RECRUITING

Study of ART6043 in Advanced/Metastatic Solid Tumors Patients

Conditions

Advanced Solid Tumor Metastatic Solid Tumor Metastatic Cancer HER2-negative Breast Cancer Poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor (PARPi)Human epidermal growth factor receptor 2 negative (HER2-ve)Oral anticancer Sensitivity to Polymerase Theta Inhibitor

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors

Quick Facts

Study Start:2023-06-30

Study Completion:2026-12-14

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05898399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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 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 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.	* 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. * 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. * First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy. * Inflammatory breast cancer.

Inclusion Criteria

Exclusion 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 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 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 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.

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

Contacts and Locations

Study Locations (Sites)

South Texas Accelerated Research Therapeutics (START) - Midwest

Grand Rapids, Michigan, 49546

United States

Memorial Sloan-Kettering Cancer Center (MSKCC)

New York, New York, 10065-6800

United States

Stephenson Cancer Center - Oncology

Oklahoma City, Oklahoma, 73104

United States

Jefferson University Hospitals - Kimmel Cancer Center

Philadelphia, Pennsylvania, 17107

United States

SCRI oncology partners

Nashville, Tennessee, 37203

United States

Mary Crowley Cancer Center - Clinic

Dallas, Texas, 75251

United States

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Artios Pharma Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-30

Study Completion Date2026-12-14

Study Record Updates

Study Start Date2023-06-30

Study Completion Date2026-12-14

Terms related to this study

Keywords Provided by Researchers

Metastatic Cancer
HER2-negative Breast Cancer
Poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor (PARPi)
Human epidermal growth factor receptor 2 negative (HER2-ve)
Oral anticancer
Sensitivity to Polymerase Theta Inhibitor

Additional Relevant MeSH Terms

Advanced Solid Tumor
Metastatic Solid Tumor