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