ART0380 for Cancer

(ARTIST Trial)

No longer recruiting at 15 trial locations

Overseen By Artios Pharma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Artios Pharma Ltd

Must not be taking: ATR inhibitors

Disqualifiers: Pregnancy, Serious systemic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 21-day cycles, up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called ART0380, a new potential drug, to evaluate its effectiveness and safety for people with certain types of cancer. It focuses on two groups: those with recurrent endometrial cancer and those with advanced solid tumors. Patients who have tried other treatments but still need help managing their cancer might be suitable, especially if their tumors have specific biological markers. The study aims to offer a new treatment option for those facing difficult-to-treat cancers. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, providing early access to potentially effective treatment options.

Will I have to stop taking my current medications?

The trial requires that you stop all previous cancer treatments for at least 21 days or 5 half-lives before starting the study, but it doesn't specify about other medications. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that ART0380 is likely to be safe for humans?

Research has shown that ART0380 is generally well tolerated by patients with various types of cancer. Early findings indicate that patients who took ART0380, either continuously or with breaks, managed it well. Most did not experience severe side effects, and the treatment appeared safe.

For patients with solid tumors, studies have demonstrated that ART0380, when used alone, is safe enough to combine with other treatments. These studies reported no major safety issues.

Regarding endometrial cancer, ART0380 is being tested for its effectiveness as a standalone treatment. While specific safety data for this group isn't detailed, results from other studies suggest that ART0380 is generally safe and well tolerated.

Overall, ART0380 appears to be a promising treatment with a good safety record. However, discussing potential side effects with healthcare professionals remains important. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for cancer?

Researchers are excited about ART0380 because it represents a potential new frontier for treating solid tumors and endometrial cancer. Unlike traditional chemotherapy, ART0380 works by selectively inhibiting a protein crucial for cancer cell survival, which could mean fewer side effects and a more targeted attack on cancer cells. This targeted approach not only aims to improve the effectiveness of treatment but also enhances patient quality of life by minimizing collateral damage to healthy cells.

What evidence suggests that ART0380 might be an effective treatment for cancer?

Research has shown that ART0380 may help treat advanced solid tumors. In this trial, participants with advanced or metastatic solid tumors will receive ART0380 monotherapy. Early results indicate that patients taking ART0380, a drug targeting a specific protein called ATR kinase, experienced positive changes, with tumors either shrinking or stopping growth. Some studies found ART0380 even more effective when combined with other treatments, such as a low dose of the drug irinotecan, which further reduced tumors.

For endometrial cancer, ART0380 also shows promise. Participants with persistent or recurrent endometrial cancer in this trial will receive ART0380 monotherapy. Some patients with aggressive forms of this cancer saw partial tumor shrinkage. This suggests that ART0380 could be a hopeful option for tumors responding to ATR inhibition. These positive findings highlight ART0380’s potential in treating challenging cancers. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

All side effects from my previous treatments have mostly gone away.

I am fully active or restricted in physically strenuous activity but can do light work.

Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.

Exclusion Criteria

Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to the protocol.

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.

My brain scans show no worsening after treatment for brain metastases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

≤28 days

Treatment

Participants receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle

21-day cycles, up to 2 years

Pre-dose Cycle 1 days 1, 2, 15, 16, 17, 18, Cycle 2 day 1, Cycle 3 day 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 6 weeks until disease progression, up to 2 years

Every 6 weeks from randomization

Overall survival follow-up

Participants are monitored for overall survival

Every 12 weeks until data cut-off

What Are the Treatments Tested in This Trial?

Interventions

• ART0380

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm 2 [ART0380 monotherapy (solid tumors patients)] Experimental Treatment 1 Intervention

Patients with advanced or metastatic solid tumors will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.

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

Patients with persistent or recurrent endometrial cancer (EC) will receive ART0380 monotherapy in one of two dose regimens for a 21-day cycle.

Who Is Running the Clinical Trial?

Artios Pharma Ltd

Lead Sponsor

Trials

6

Recruited

1,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05798611

Study of ART0380 in Patients With Biologically Selected ... 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 ...

2. artios.com artios.com/wp-content/uploads/2023/11/ART0380-ESMO-Poster-2023.pdf

ART0380-ESMO-Poster-2023.pdf ART0380 was shown to be clinically effective with patients who received ART0380 experiencing both molecular ... endometrial cancer. High grade endometrial cancer.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10962462/

Novel Molecular Targets in Endometrial Cancer OS at 24 months for all comers was 71.3% with dostarlimab and 56.0% with placebo (HR 0.64; 95% CI: 0.46–0.87). The second trial (NRG-GY018) ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)02703-5/fulltext

680P First results from the phase I trial of the ATR inhibitor, ... PK data show ART0380 is rapidly absorbed ... Confirmed partial responses were observed in 3 pts with endometrial adenocarcinoma and 1 pt with anal cancer.

5. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_2/CT267/761473/Abstract-CT267-First-results-of-ART0380-an-ATR

Abstract CT267: First results of ART0380 (an ATR kinase ... Patients (pts) with advanced cancers who had no satisfactory alternative treatment option received escalating doses of ART0380 (25mg to 400mg) ...

6. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(24)00798-4/fulltext

A phase II, open-label, multicenter, basket study of the ATR ... ART0380 is a highly competitive, oral, selective ATR inhibitor being studied as monotherapy and in combination with chemotherapies and is now in phase II ...

7. careacross.com careacross.com/clinical-trials/trial/NCT05798611

Study of ART0380 in Patients With Biologically Selected ... The study will recruit selected patients with advanced or metastatic solid tumors, specifically: - Patients with persistent or recurrent endometrial cancer (EC) ...