Study of ART0380 in Patients With Biologically Selected Solid Tumors
a study on Solid Tumor Endometrial Cancer Cancer, General Metastatic Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedcompletion around
Description
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).
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)
Details
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.
Keywords
Advanced Solid Tumor, Recurrent Endometrial Cancer, Metastatic Cancer, Solid Tumors, Monotherapy, Cancer cell, Oral anti-cancer, Endometrial Neoplasms, ART0380
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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.
- P-glycoprotein or breast cancer resistance protein (BCRP) inhibitors
- 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.
Locations
- University of California Los Angeles (UCLA)
not yet accepting patients
Los Angeles California 90095-1781 United States - University of Oklahoma/Sarah Cannon Research Institute
accepting new patients
Oklahoma City Oklahoma 73104 United States - The University of Chicago
accepting new patients
Chicago Illinois 60637-1447 United States
Details
- Status
- accepting new patients at some sites,
but this study is not currently recruiting here - Start Date
- Completion Date
- (estimated)
- Sponsor
- Artios Pharma Ltd
- ID
- NCT05798611
- Phase
- Phase 2 research study
- Study Type
- Interventional
- Participants
- Expecting 60 study participants
- Last Updated