ART0380 for Advanced Cancer

Recruiting at 43 trial locations

Overseen By Sarah Cannon Development Innovations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Artios Pharma Ltd

Must not be taking: UGT1A1 inhibitors

Disqualifiers: Pregnancy, HIV/AIDS, Hepatitis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21-day cycles

547 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan

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, whichever is shorter, before starting the study. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.

Research Team

Antonio Gonzalez, MD, PHD

Principal Investigator

Clinica Universidad de Navarra, Madrid

Melissa Johnson, MD

Principal Investigator

Tennessee Oncology

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, including specific types of ovarian, fallopian tube, and peritoneal cancers. Participants must have a measurable lesion, be in good physical condition (ECOG 0-1), not have had certain prior treatments or uncontrolled brain issues, and agree to use effective contraception.

Inclusion Criteria

I stopped all cancer treatments at least 21 days ago and have recovered from their immediate side effects.

I can take care of myself and perform daily activities.

I haven't been treated with gemcitabine alone for my condition.

Exclusion Criteria

Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

I do not plan to father a child during the study or within 4 months after it ends.

Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 4 weeks after the last administration of study treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ART0380 as monotherapy or in combination with gemcitabine or irinotecan in 21-day cycles

21-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Progression free survival is assessed every 6 weeks for 18 weeks, then every 9 weeks up to approximately 24 months

24 months

Treatment Details

Interventions

• ART0380

Trial Overview The study tests ART0380 alone and alongside gemcitabine or irinotecan to determine the safest dose, understand side effects better, and evaluate effectiveness against these cancers. It involves patients who've had no luck with standard therapies or those without existing options.

Participant Groups

Group I: Part B5 Experimental Treatment 2 Interventions

In Part B5, up to 80 participants with colorectal cancer (CRC) will receive ART0380 in combination with irinotecan on a 21-day cycle.

Group II: Part B4 Experimental Treatment 1 Intervention

In Part B4, up to 40 participants 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 III: Part B3 Experimental Treatment 1 Intervention

in Part B3, up to 40 participants 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..

Group IV: Part B2 Experimental Treatment 2 Interventions

In Part B2, up to 60 participants with high grade serous ovarian, primary peritoneal, or fallopian tube carcinoma will be randomized (open label) 1:1 to either ART0380 in combination with gemcitabine or gemcitabine alone.

Group V: Part B1 Experimental Treatment 3 Interventions

In Part B1, up to 7 cohorts making up to a total of approximately 220 participants with solid cancers with alterations in the ATM (ataxia-telangiectasia mutated) gene likely to predict for loss of ATM protein will be treated with either * ART0380 monotherapy Or * ART0380 in combination with irinotecan

Group VI: Part A3 Experimental Treatment 2 Interventions

Part A3 will evaluate intermittent dosing of ART0380 in combination with irinotecan in 21-day cycles. Up to approximately 36 participants will participate in this dose escalation arm.

Group VII: Part A2 Experimental Treatment 2 Interventions

Part A2 will evaluate intermittent dosing of ART0380 in combination with gemcitabine in 21-day cycles. Up to 21 participants will participate in this dose escalation arm.

Group VIII: Part A1 Experimental Treatment 1 Intervention

Part A1 will evaluate intermittent and continuous dosing of ART0380 monotherapy. Treatment will be given in 21-day cycles. Up to 50 participants will participate in this dose-escalation arm.

Who Is Running the Clinical Trial?

Artios Pharma Ltd

Lead Sponsor

Trials

6

Recruited

1,600+