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Trial Title: Study of ART0380 in Patients With Biologically Selected Solid Tumors

NCT ID: NCT05798611

Condition: Advanced Solid Tumor
Recurrent Endometrial Cancer
Metastatic Cancer

Conditions: Official terms:
Endometrial Neoplasms

Conditions: Keywords:
Solid Tumors
Monotherapy
Cancer cell
Oral anti-cancer

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ART0380
Description: Randomized patients will orally receive ART0380.
Arm group label: Arm 1 [ART0380 monotherapy (endometrial cancer patients)]
Arm group label: Arm 2 [ART0380 monotherapy (solid tumors patients)]

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).

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.

Criteria for eligibility:
Criteria:
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 receiving potent inhibitors and inducers of CYP3A4 or CYP3A4 substrates which have a narrow therapeutic range or CYP3A4 sensitive substrates within 2 weeks before the first dose of study treatment will be excluded. - Patients receiving the following within 2 weeks of the first dose will be excluded from study treatment. 1. P-glycoprotein or breast cancer resistance protein (BCRP) inhibitors 2. Statins - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of California Los Angeles (UCLA)

Address:
City: Los Angeles
Zip: 90095-1781
Country: United States

Status: Not yet recruiting

Facility:
Name: The University of Chicago

Address:
City: Chicago
Zip: 60637-1447
Country: United States

Status: Recruiting

Facility:
Name: Dana Farber Cancer Center

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Facility:
Name: Northwell Health R.J. Zuckerberg Cancer Center

Address:
City: Lake Success
Zip: 11042
Country: United States

Status: Recruiting

Facility:
Name: Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital - Oncology

Address:
City: New York
Zip: 10065
Country: United States

Status: Recruiting

Facility:
Name: University of Oklahoma/Sarah Cannon Research Institute

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Status: Recruiting

Facility:
Name: Western Pennsylvania Hospital

Address:
City: Pittsburgh
Zip: 15224
Country: United States

Status: Recruiting

Facility:
Name: Women and Infants Hospital

Address:
City: Providence
Zip: 02905
Country: United States

Status: Recruiting

Facility:
Name: Institut de Cancérologie de l'Ouest

Address:
City: Angers
Zip: 49055
Country: France

Status: Recruiting

Facility:
Name: Centre Francois Baclesse - Service d'Oncologie médicale

Address:
City: Caen
Zip: 14076
Country: France

Status: Recruiting

Facility:
Name: Hopital Cochin Saint Vincent De Paul

Address:
City: Paris
Zip: 75014
Country: France

Status: Recruiting

Facility:
Name: Hopital Lyon Sud

Address:
City: Pierre-Benite
Zip: 69310
Country: France

Status: Recruiting

Facility:
Name: Centre Hospitalier Universitaire De Poitiers

Address:
City: Poitiers
Zip: 86000
Country: France

Status: Recruiting

Facility:
Name: Hospital Universitario De Jaén

Address:
City: Jaén
Zip: 23007
Country: Spain

Status: Recruiting

Facility:
Name: Fundación Instituto Valenciano De Oncología

Address:
City: Valencia
Zip: 46009
Country: Spain

Status: Recruiting

Start date: September 6, 2023

Completion date: March 2025

Lead sponsor:
Agency: Artios Pharma Ltd
Agency class: Industry

Source: Artios Pharma Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05798611

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