What side effects are associated with this type of intervention?

Common treatments for endometrial cancer include chemotherapy, radiation therapy, and hormone therapy. Chemotherapy, often involving agents like paclitaxel and carboplatin, can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection due to lowered blood cell counts. Radiation therapy may lead to skin irritation, fatigue, and gastrointestinal issues like diarrhea. Hormone therapy, used particularly for hormone receptor-positive tumors, can result in side effects like hot flashes, vaginal dryness, and an increased risk of blood clots. While specific data on ATR inhibitors like ART0380 in endometrial cancer is limited, potential side effects based on similar treatments could include fatigue, gastrointestinal disturbances, and hematologic toxicities.

What prior FDA approvals exist?

FDA approvals for the treatment of endometrial cancer have included various hormonal therapies, chemotherapy agents, and targeted therapies. Hormonal therapies such as progestins and aromatase inhibitors have been used, although with varying success rates. Chemotherapy agents like doxorubicin and paclitaxel are commonly employed. Targeted therapies, including mTOR inhibitors like everolimus, have shown promise when combined with hormonal treatments. While specific FDA approvals for ATR inhibitors in endometrial cancer are not detailed, ongoing trials like ART0380 are exploring the potential of ATR inhibition in treating biologically selected solid tumors, which may include endometrial cancer in the future.

What other types of research exist?

Promising novel alternatives to ART0380 for endometrial cancer patients include: 1) Lenvatinib plus Pembrolizumab, which has shown improved progression-free survival and overall survival in advanced endometrial cancer patients, as demonstrated in the Study 309/KEYNOTE-775 trial. 2) PARP inhibitors like Olaparib, especially for patients with BRCA mutations, which have shown clinical and radiographic responses in endometrial cancer. These alternatives offer targeted approaches that have demonstrated efficacy in recent clinical trials.

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ATR Inhibitor

ART0380 for Cancer (ARTIST Trial)

Phase 2

Recruiting

Research Sponsored by Artios Pharma Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until disease progression (every 6 weeks from randomization upto 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ART0380, an oral cancer drug, in patients with advanced or hard-to-treat cancers. The drug targets a protein that helps cancer cells repair their DNA, making it harder for the cancer to survive. BO-1051 is a new anti-cancer drug that can effectively target a variety of cancer cell lines and inhibit tumor growth.

Who is the study for?

This trial is for adults with certain types of advanced endometrial or solid tumors predicted to respond to ATR inhibition. Participants must have stopped previous cancer treatments, have good organ function, use effective contraception if childbearing potential exists, and not be pregnant. They should also have a life expectancy over 12 weeks and a performance status allowing daily activity.

What is being tested?

The study tests ART0380 as a single therapy in patients selected based on their tumor biology's likelihood to respond well to blocking the ATR protein kinase. It aims to assess how effective and safe this treatment is for these specific cancers.

What are the potential side effects?

While the side effects of ART0380 are not detailed here, similar drugs often cause fatigue, nausea, blood count changes, increased risk of infection due to immune system impact, liver function alterations, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until disease progression (every 6 weeks from randomization upto 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until disease progression (every 6 weeks from randomization upto 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until disease progression (every 6 weeks from randomization upto 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Area under the plasma concentration-time curve from zero to infinity (AUC0-inf)

Best overall response (BOR)

Change in tumor size

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 [ART0380 monotherapy (solid tumors patients)]Experimental Treatment1 Intervention

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.

Group II: Arm 1 [ART0380 monotherapy (endometrial cancer patients)]Experimental Treatment1 Intervention

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endometrial cancer treatments primarily include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Surgery involves the removal of the uterus and possibly other affected tissues. Radiation therapy uses high-energy rays to kill cancer cells. Chemotherapy employs drugs like paclitaxel and carboplatin to destroy rapidly dividing cells. Hormone therapy targets hormone receptors to slow cancer growth, particularly in hormone receptor-positive tumors. Targeted therapies, such as ATR inhibitors like ART0380, focus on specific molecular pathways involved in cancer cell survival and proliferation. ATR inhibition disrupts the DNA damage response, making cancer cells more susceptible to treatment. Understanding these mechanisms helps tailor treatments to individual patients, potentially improving outcomes and reducing side effects.

Constitutively active ESR1 mutations in gynecologic malignancies and clinical response to estrogen-receptor directed therapies.Developments in the systemic treatment of endometrial cancer.