Study of ART0380 in Patients With Biologically Selected Solid Tumors

Stopped early · Phase 2

Conditions studied: Advanced Solid Tumor, Recurrent Endometrial Cancer, Metastatic Cancer

In brief

This interventional study will evaluate the efficacy and safety of ART0380 as monotherapy in patients whose tumors have a biology to predict for sensitivity to inhibition of Ataxia-Telangiectasia Mutated and Rad3-related protein kinase (ATR).

Key facts

Study ID

NCT05798611

Run by

Artios Pharma Ltd

People needed

36

Starts

2023-09-06

Expected to finish

2025-05-27

Last updated by the study team

2025-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have discontinued all previous treatments for cancer for at least 21 days or 5 half-lives (not including palliative radiotherapy at focal sites), whichever is shorter. Palliative radiotherapy must have completed 1 week prior to start of study treatment.
• Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, neuropathy, and alopecia, which must have resolved to Grade ≤2).
• 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.
• Performance status of 0-1 on the Eastern Cooperative Oncology Group scale.
• Have a non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available.
• Inclusion Criteria specific to each Arm
• Inclusion Criteria for Arm 1 [ART0380 monotherapy (endometrial cancer patients)]
• Persistent or recurrent EC with biological selection.
• Patients should have received taxane/platinum chemotherapy unless contraindicated.
• Measurable disease.
• Inclusion Criteria for Arm 2 [ART0380 monotherapy (solid tumors patients)]
• Advanced or metastatic solid cancers of any histology with biological selection.
• If a Programmed cell death protein-1 /Programmed death-ligand-1 inhibitor (e.g., pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study.
• Radiologically evaluable disease.

You may not qualify if…

• Patients who are pregnant.
• Prior treatment with an inhibitor of ATR, WEE1, checkpoint kinase 1 or PKMYT1.
• Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to the protocol.
• Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression.
• Have any major gastrointestinal issues that could impact absorption of ART0380.
• Have a history of allergy or hypersensitivity to study drug components.
• Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.
• Patients who plan to father a child while in the study or within 16 weeks (5 months in France) after the last administration of study treatment.

Where it is running

• University of California Los Angeles (UCLA) — Los Angeles, California, United States
• The University of Chicago — Chicago, Illinois, United States
• Dana Farber Cancer Center — Boston, Massachusetts, United States
• Northwell Health R.J. Zuckerberg Cancer Center — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital - Oncology — New York, New York, United States
• University of Oklahoma/Sarah Cannon Research Institute — Oklahoma City, Oklahoma, United States
• Western Pennsylvania Hospital — Pittsburgh, Pennsylvania, United States
• Women and Infants Hospital — Providence, Rhode Island, United States
• Institut de Cancérologie de l'Ouest — Angers, NAP, France
• Centre Francois Baclesse - Service d'Oncologie médicale — Caen, NAP, France
• Hopital Cochin Saint Vincent De Paul — Paris, NAP, France
• Hopital Lyon Sud — Pierre-Bénite, NAP, France
• Centre Hospitalier Universitaire De Poitiers — Poitiers, NAP, France
• Hospital Universitario De Jaén — Jaén, Andalusia, Spain
• Fundación Instituto Valenciano De Oncología — Valencia, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.