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Experimental cancer drug ART0380 trial halted early

NCT ID NCT05798611

Disease control Sponsor: Artios Pharma Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called ART0380 in 36 people with advanced or metastatic solid tumors, including endometrial cancer. The drug was taken by mouth and aimed to shrink tumors by blocking a protein involved in cancer cell growth. The trial was terminated early, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ART0380 (an ATR kinase inhibitor taken orally)
What this could lead to
If successful, ART0380 could offer a new treatment option for people with advanced solid tumors that have specific genetic features.
What could go wrong
This trial was terminated early, so results are limited. The drug is still experimental, and its safety and effectiveness are not yet proven. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

36 people

The number who actually took part.

Started

Sep 2023

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic cancer Recurrent endometrial cancer

Contacts and locations

Locations

  • Centre Francois Baclesse - Service d'Oncologie médicale

    Caen, NAP, 14076, France

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers, NAP, 86000, France

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02215, United States

  • Fundación Instituto Valenciano De Oncología

    Valencia, 46009, Spain

  • Hopital Cochin Saint Vincent De Paul

    Paris, NAP, 75014, France

  • Hopital Lyon Sud

    Pierre-Bénite, NAP, 69310, France

  • Hospital Universitario De Jaén

    Jaén, Andalusia, 23007, Spain

  • Institut de Cancérologie de l'Ouest

    Angers, NAP, 49055, France

  • Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital - Oncology

    New York, New York, 10065, United States

  • Northwell Health R.J. Zuckerberg Cancer Center

    Lake Success, New York, 11042, United States

  • The University of Chicago

    Chicago, Illinois, 60637-1447, United States

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095-1781, United States

  • University of Oklahoma/Sarah Cannon Research Institute

    Oklahoma City, Oklahoma, 73104, United States

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Women and Infants Hospital

    Providence, Rhode Island, 02905, United States

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