Clinical Trial Finder

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.

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.

Arms

Experimental: Arm 1 [ART0380 monotherapy (endometrial cancer patients)]

Patients with persistent or recurrent endometrial cancer (EC) will receive ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle.

Experimental: Arm 2 [ART0380 monotherapy (solid tumors patients)]

Patients with advanced or metastatic solid tumors will receive ART0380 monotherapy on either a continuous daily dose or on an intermittent schedule for a 21-day cycle.

Interventions

Drug: - ART0380

Randomized patients will orally receive ART0380.