ART0380 for Cancer

(ARTIST Trial)

Recruiting at 14 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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+