Clinical trial · Interventional
Study of ART0380 in Patients With Biologically Selected Solid Tumors
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision, not for reasons affecting the benefit-risk balance.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ART0380 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 [ART0380 monotherapy (endometrial cancer patients)]
- description
- Patients with persistent or recurrent endometrial cancer (EC) will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.
- interventionNames
- Drug: ART0380
- type
- EXPERIMENTAL
- label
- Arm 2 [ART0380 monotherapy (solid tumors patients)]
- description
- Patients with advanced or metastatic solid tumors will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.
- interventionNames
- Drug: ART0380
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available