Study of ART0380 in Patients With Biologically Selected Solid Tumors
NCT ID: NCT05798611
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
36 participants
INTERVENTIONAL
2023-09-06
2025-05-27
Brief Summary
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Detailed Description
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The study will recruit selected patients with advanced or metastatic solid tumors, specifically:
* Patients with persistent or recurrent endometrial cancer (EC)
* Patients with advanced or metastatic solid tumors of any histology
Above patients will be randomized in a 1:1 ratio to one of two dose regimens of ART0380.
Safety will be evaluated on a quarterly basis, at a minimum. Patients may continue to receive ART0380 as long as they are continuing to derive benefit from treatment or until disease progression, withdrawal of consent, or until they experience unacceptable drug-related toxicity.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 [ART0380 monotherapy (endometrial cancer patients)]
Patients with persistent or recurrent endometrial cancer (EC) will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.
ART0380
Randomized patients will orally receive ART0380.
Arm 2 [ART0380 monotherapy (solid tumors patients)]
Patients with advanced or metastatic solid tumors will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.
ART0380
Randomized patients will orally receive ART0380.
Interventions
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ART0380
Randomized patients will orally receive ART0380.
Eligibility Criteria
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Inclusion Criteria
* 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.
* Persistent or recurrent EC with biological selection.
* Patients should have received taxane/platinum chemotherapy unless contraindicated.
* Measurable disease.
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Artios Pharma Ltd
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2023-504153-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ART0380C004
Identifier Type: -
Identifier Source: org_study_id