Study of ART0380 in Patients With Biologically Selected Solid Tumors
Megadott ok: Sponsor decision, not for reasons affecting the benefit-risk balance.
Key facts
- Where
- Boston, Chicago, Lake Success, Los Angeles, New York, Oklahoma City, Pittsburgh és Providence, Egyesült ÁllamokSee the 8 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- Dana Farber Cancer CenterBoston, Egyesült ÁllamokNo longer taking part
- The University Of ChicagoChicago, Egyesült ÁllamokNo longer taking part
- Northwell Health/R.J. Zuckerberg Cancer CenterLake Success, Egyesült ÁllamokNo longer taking part
- University of California Los Angeles (UCLA).Los Angeles, Egyesült ÁllamokNo longer taking part
- Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital - OncologyNew York, Egyesült ÁllamokNo longer taking part
- University of Oklahoma/Sarah Cannon Research InstituteOklahoma City, Egyesült ÁllamokNo longer taking part
- Western Pennsylvania HospitalPittsburgh, Egyesült ÁllamokNo longer taking part
- Women and Infants HospitalProvidence, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Artios Pharma Ltd
- Trial code
- NCT05798611
- Record updated
- 2025. november 6.
- Original description
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 full original descriptionShow less
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).
Inclusion: 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; 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: 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; 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 a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment; Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic); Have a history of allergy or hypersensitivity to study drug components; Patients who are pregnant; Have any major gastrointestinal issues that could impact absorption of ART0380; 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.