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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities (DLTs) from ART0380 monotherapy and in combination with gemcitabine or irinotecan

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

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

Secondary outcome measures

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

Part B2: Number of participants with adverse events following administration of ART0380 in combination with gemcitabine or gemcitabine alone

Parts A1, A2, A3, B1, B2, B3 and B4: Duration of response based on RECIST 1.1

+5 more

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part B4Experimental 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: Part B3Experimental Treatment1 Intervention

Part B3: 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..

Group III: Part B2Experimental Treatment2 Interventions

In Part B2, up to 110 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 IV: Part B1Experimental Treatment3 Interventions

In Part B1, up to 6 cohorts making up to a total of approximately 180 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 V: Part A3Experimental Treatment2 Interventions

Part A3 will evaluate intermittent dosing of ART0380 in combination with irinotecan in 21-day cycles. Up to approximately 12 participants will participate in this dose escalation arm.

Group VI: 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 VII: 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

~2070

Irinotecan

2017

Completed Phase 4

~2680

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Artios Pharma LtdLead Sponsor

5 Previous Clinical Trials

1,049 Total Patients Enrolled

Antonio Gonzalez, MD, PHDStudy ChairClinica Universidad de Navarra, Madrid

Melissa Johnson, MDStudy ChairTennessee Oncology

6 Previous Clinical Trials

420 Total Patients Enrolled

1 Trials studying Ovarian Cancer

34 Patients Enrolled for Ovarian Cancer

Media Library

ART0380 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04657068 — Phase 1 & 2

Ovarian Cancer Research Study Groups: Part B3, Part B4, Part A1, Part A2, Part A3, Part B1, Part B2

Ovarian Cancer Clinical Trial 2023: ART0380 Highlights & Side Effects. Trial Name: NCT04657068 — Phase 1 & 2

ART0380 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04657068 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please list how many hospitals are trialing this medication?

"To make participation easy, this trial is being run in 10 locations which are situated in Dallas, Oklahoma City, West Palm Beach and other cities. To limit your travel burden, please try to choose the clinic that is closest to you."

Answered by AI

How many people can sign up for this experiment at most?

"That is correct, the website clinicaltrials.gov has information suggesting that this particular trial is looking for new participants. The study was posted on 1/13/2021 and updated as recently as 7/6/2022. They are seeking a total of 232 individuals from 10 different locations."

Answered by AI

Are investigators looking for new participants at this time?

"The most recent information available on clinicaltrials.gov suggests that this trial is open and looking for participants. The study was first posted on 1/13/2021 with the latest edit being made on 7/6/2022."

Answered by AI

Do we have any other data on the efficacy of ART0380?

"There are 464 ongoing studies and 137 in Phase 3 that are looking into the efficacy of ART0380. While some trials are based in Woolloongabba, Queensland, there numerous other locations with 24699 active clinical trials for ART0380."

Answered by AI

What are the conditions that ART0380 is approved to treat by the FDA?

"ART0380 is most frequently used to treat small cell lung cancer (sclc), but has also been shown to be an effective treatment for head and neck carcinoma, pancreatic adenocarcinoma locally advanced, and cervical cancers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

2020. "A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04657068.

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