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Advanced Solid TumorPhase 2ARTISTNCT05798611

Study of ART0380 in Patients With Biologically Selected Solid Tumors

A Phase 2 study testing ART0380 in people with Advanced Solid Tumor and Recurrent Endometrial Cancer, run by Artios Pharma Ltd at 15 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ART0380
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
15 sitesin 3 countries
Study dates
6 Sep 2023to 27 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Have a non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

United States8 sites

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02215

  • The University of Chicago

    Chicago, Illinois, 60637-1447

  • Northwell Health R.J. Zuckerberg Cancer Center

    Lake Success, New York, 11042

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095-1781

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

    New York, New York, 10065

  • University of Oklahoma/Sarah Cannon Research Institute

    Oklahoma City, Oklahoma, 73104

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

Other trials in United States

France5 sites

  • Institut de Cancérologie de l'Ouest

    Angers, NAP, 49055

  • Centre Francois Baclesse - Service d'Oncologie médicale

    Caen, NAP, 14076

  • Hopital Cochin Saint Vincent De Paul

    Paris, NAP, 75014

  • Hopital Lyon Sud

    Pierre-Bénite, NAP, 69310

  • Centre Hospitalier Universitaire De Poitiers

    Poitiers, NAP, 86000

Other trials in France

Spain2 sites

  • Hospital Universitario De Jaén

    Jaén, Andalusia, 23007

  • Fundación Instituto Valenciano De Oncología

    Valencia, 46009

Other trials in Spain

About this study

Official title: A Phase II, Open-label, Multi-center, Basket Study of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy to Patients With Biologically Selected Advanced or Metastatic Solid Tumors (ARTIST)

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).

Read the detailed description

ART0380 is being developed as an oral anti-cancer agent for the treatment of patients with cancers that have defects in deoxyribonucleic acid (DNA) repair.

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.

Being tested
ART0380
Keywords
Solid Tumors, Monotherapy, Cancer cell, Oral anti-cancer
Medical subject headings
Endometrial Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ART0380Drug

    Randomized patients will orally receive ART0380.

Study groups in NCT05798611
Study groupRoleWhat they receive
Arm 1 [ART0380 monotherapy (endometrial cancer patients)]ExperimentalPatients with persistent or recurrent endometrial cancer (EC) will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.
Receives: Drug: ART0380
Arm 2 [ART0380 monotherapy (solid tumors patients)]ExperimentalPatients with advanced or metastatic solid tumors will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.
Receives: Drug: ART0380

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined as the proportion of patients with a complete response (CR) or partial response (PR) to treatment according to Response evaluation criteria in solid tumors (RECIST v1.1).

    Measured: Until disease progression (Every 6 weeks from randomization Upto 2 Years)

Secondary outcomes (10)

  1. Number of patients with adverse events

    To assess the safety and tolerability of ART0380 in patients with solid tumors.

    Measured: From Cycle 1 (each Cycle is 21-day) Day 1 until 30-day follow-up visit (Upto 2 Years)

  2. Progression free survival (PFS)

    The PFS is defined as the time from randomization until the earliest objective disease progression defined by RECIST v1.1 or Prostate Cancer Working Group 3 (PCWG-3) (for patients with prostate cancer in Arm 2) or death by any cause in the absence of progression, regardless of whether the patient withdraws from study medication or receives another anti-cancer therapy prior to progression.

    Measured: Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)

  3. Best overall response (BOR)

    The best overall response is the best response (complete response, and partial response) recorded from the date of randomization for each patient until the progression or censoring date in the absence of progression.

    Measured: Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)

  4. Disease control rate (DCR)

    To further explore the efficacy of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.

    Measured: Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)

  5. Duration of response (DOR)

    The DOR will be defined for patients with a BOR of CR/PR, as the time from the date of first documented response until date of documented progression (by RECIST v1.1) or death in the absence of disease progression.

    Measured: Screening (≤28 days) Until disease progression or death (Every 6 weeks from randomization Upto 2 Years)

  6. Change in tumor size

    The best percentage change in tumor size from baseline will be determined for each patient, ie, the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction.

    Measured: Screening (≤28 days) Until disease progression (Every 6 weeks from randomization Upto 2 Years)

  7. Overall survival (OS)

    The OS is defined as the time from the randomization until death due to any cause.

    Measured: Screening (≤28 days) Until overall survival follow-up (Every 12 weeks until data cut-off)

  8. Maximum plasma concentration (Cmax)

    To determine the Cmax of ART0380 following single oral dosing of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.

    Measured: Pre-dose Cycle 1 day 1, 2, 15, 16, 17, 18, Cycle 2 day 1, Cycle 3 day 1 Upto 2 Years (Each Cycle is 21-days)

  9. Half life (t1/2)

    To determine the t1/2 of ART0380 following single oral dosing of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.

    Measured: Pre-dose Cycle 1 days 1, 2, 15, 16, 17, 18, Cycle 2 day 1, Cycle 3 day 1 Upto 2 Years (Each Cycle is 21-days)

  10. Area under the plasma concentration-time curve from zero to infinity (AUC0-inf)

    To determine the AUC0-inf of ART0380 following single oral dosing of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.

    Measured: Pre-dose Cycle 1 days 1, 2, 15, 16, 17, 18, Cycle 2 day 1, Cycle 3 day 1 Upto 2 Years (Each Cycle is 21-days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start6 Sep 2023
  3. Primary completion15 Nov 2024
  4. Study completion27 May 2025

Why it stopped: Sponsor decision, not for reasons affecting the benefit-risk balance.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05798611
Sponsor's protocol ID
ART0380C004
Other IDs
2023-504153-12, 2023
Acronym
ARTIST
Status last verified
Nov 2025
First submitted
23 Mar 2023
Last updated
6 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ART0380 in people with Advanced Solid Tumor and Recurrent Endometrial Cancer, run by Artios Pharma Ltd at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision, not for reasons affecting the benefit-risk balance.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Until disease progression (Every 6 weeks from randomization Upto 2 Years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05798611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.

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