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Monoclonal Antibodies

ART0380 for Advanced Cancer

Phase 1 & 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

Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.

Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale

Must not have

Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment

Significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cycle 1 day 1 until up to 30 days after the last dose of art0380. each cycle is 21 days.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, ART0380, for safety and effectiveness in treating advanced solid tumors. The main goals are to find the safe dose and to learn more about the side effects and effectiveness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to drug infusion, possible organ inflammation due to immune response changes caused by ART0380; gemcitabine may cause nausea and low blood counts; irinotecan can lead to diarrhea and weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can take care of myself and perform daily activities.

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I have never been treated with drugs targeting the ATR/CHK1 pathway.

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My blood, kidney, liver, and clotting tests are normal without needing help.

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My cancer got worse within 6 months after platinum chemotherapy, but it didn't worsen during the treatment.

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My advanced cancer is treatable with gemcitabine, even if I've had it before.

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My advanced cancer does not respond to standard treatments, or there are no treatments available.

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My advanced cancer is treatable with irinotecan, and I may have had it before.

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I am fully active or can carry out light work.

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

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I have at least one tumor that can be seen and measured on scans.

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I am able to get out of my bed or chair and move around.

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I have a serious type of ovarian, fallopian tube, or peritoneal cancer that cannot be cured.

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My advanced cancer has ATM gene changes leading to loss of ATM protein.

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I can provide a sample of my tumor that has not been exposed to radiation for ATM protein analysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain or spinal issues due to cancer that need treatment now.

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I haven't had a severe bleeding episode or a bleeding disorder in the last 3 months.

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I do not have HIV/AIDS, hepatitis B or C, tuberculosis, or another cancer not in remission.

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I have a serious heart valve problem.

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I have moderate or severe heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from cycle 1 day 1 until up to 30 days after the last dose of art0380. each cycle is 21 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from cycle 1 day 1 until up to 30 days after the last dose of art0380. each cycle is 21 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 day 1 until up to 30 days after the last dose of art0380. each cycle is 21 days. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part B2: Progression free survival by RECIST 1.1 in participants receiving ART0380 in combination with gemcitabine or gemcitabine alone

Parts B1/B3/B4/B5: Number of participants with adverse events following administration of ART0380 monotherapy and/or in combination with irinotecan

Secondary study objectives

Assess tumor biopsies by immunohistochemistry (IHC) for loss of Ataxia Telangiectasia Mutated (ATM) protein

Pharmacokinetic Analysis (single and multiple dose where the data allow)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part B5Experimental Treatment2 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 B4Experimental Treatment1 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 B3Experimental Treatment1 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 B2Experimental Treatment2 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 B1Experimental Treatment3 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 A3Experimental Treatment2 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 A2Experimental Treatment2 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 A1Experimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Irinotecan

2017

Completed Phase 3

~2590