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ART4215 for Advanced Cancer

Q: Across how many different locations is this trial taking place?

So far, 7 patients have been enrolled in this trial at locations including Yale School of Medicine, <a href="https://www.withpower.com/clinical-trials/oklahoma">Oklahoma</a> University, and University of <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>/Abramson <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center. There are also 7 other sites where recruitment is ongoing.

Q: Are there any available openings for participants in this research project?

The most recent information available on clinicaltrials.gov suggests that this study is still actively recruiting patients. The trial was initially posted on September 13th, 2021 and updated as recently as October 5th, 2022.

Q: How many individuals are participating in this clinical trial?

That is correct, the online information hosted on clinicaltrials.gov indicates that this study is looking for more participants. The trial was first posted September 13th 2021 and has since been updated October 5th of this year. They are recruiting a total of 206 patients from 7 different locations.

Q: Are there case studies of ART4215's success?

ART4215 was first studied a decade ago at City of Hope. So far, there have been 32 completed studies and 60 more that are ongoing. A significant portion of these live clinical trials are based in New Haven, <a href="https://www.withpower.com/clinical-trials/connecticut">Connecticut</a>.

Phase 1 & 2

Waitlist Available

Research Sponsored by Artios Pharma Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Additional inclusion criteria for participants in dose expansion (Part B3): HER2-negative locally advanced or metastatic breast cancer. Deleterious or suspected deleterious germline or somatic BRCA1 or BRCA2 mutation. No more than 3 prior chemotherapy-inclusive regimens (including antibody conjugates). Prior treatment with a taxane or anthracycline unless contraindicated. No or </= 1 month of prior treatment with a PARP inhibitor. At least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis

At least 1 radiologically evaluable lesion that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 for patients with prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose until up to 30 days after the last dose of art4215. each cycle is 21 days.

Awards & highlights

Study Summary

This trial is testing a new drug, ART4215, on people with advanced cancer. The goal is to learn more about the side effects and effectiveness of the drug.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors suitable for PARP inhibitor treatment. Eligible participants may have had prior chemotherapy but not more than three regimens, and no previous PARP inhibitors unless specified. They must have at least one measurable tumor lesion, adequate organ function, and agree to use effective contraception.Check my eligibility

What is being tested?

ART4215 is being tested alone and alongside talazoparib or niraparib in patients with various cancers including breast cancer. The study aims to determine the safe dosage levels, side effects profile, and effectiveness of these treatments in combating cancer progression.See study design

What are the potential side effects?

Potential side effects include reactions related to drug infusion, fatigue, digestive issues like nausea or constipation, blood cell count changes increasing infection risk, liver or kidney function alterations. Specific side effect profiles will be studied during the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 28 days prior to the first dose of art4215.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 28 days prior to the first dose of art4215.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 28 days prior to the first dose of art4215. 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: Number of participants with dose limiting toxicities (DLTs) from ART4215 monotherapy, in combination with talazoparib or in combination with niraparib

Part B1 and B2: Number of participants with adverse events following administration of ART4215

Part B3: Progression free survival (PFS) as a measure of efficacy for ART4215 in combination with talazoparib or talazoparib alone

Secondary outcome measures

Assessment of lesions in (or indicative of lesions in) DNA repair pathways by immunohistochemistry for loss of shieldin complex and/or TP53BP1 or other relevant pathways

Best overall response (BOR) as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib

Change in tumor size as a measure of efficacy for ART4215 as monotherapy, in combination with talazoparib or in combination with niraparib

+18 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part B3Experimental Treatment2 Interventions

In Part B3, approximately 120 participants with HER2 negative BRCA breast cancers will be randomized 1:1 to either ART4215 in combination with talazoparib or talazoparib alone.

Group II: Part B2Experimental Treatment1 Intervention

In Part B2 dose expansion, up to 20 participants with solid cancers with characteristics indicative of sensitivity to pol theta inhibition will receive ART4215.

Group III: Part B1Experimental Treatment1 Intervention

In Part B1 dose expansion, up to 30 participants with solid cancers that have been treated with a PARP inhibitor for an approved indication will receive ART4215.

Group IV: Part A3Experimental Treatment2 Interventions

Part A3 will evaluate ART4215 given in combination with niraparib in 21-day cycles. Up to 30 participants will participate in this dose escalation arm.

Group V: Part A2Experimental Treatment2 Interventions

Part A2 will evaluate ART4215 given in combination with talazoparib in 21 day cycles. Up to 50 participants will participate in this dose escalation arm.

Group VI: Part A1Experimental Treatment1 Intervention

Part A1 will evaluate ART4215 monotherapy administered in 21 day cycles. Up to 90 participants will participate in this dose escalation arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

2021

Completed Phase 2

~2770

Niraparib

2018

Completed Phase 4

~1540

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Artios Pharma LtdLead Sponsor

5 Previous Clinical Trials

1,121 Total Patients Enrolled

1 Trials studying Breast Cancer

120 Patients Enrolled for Breast Cancer

Timothy Yap, MBBS, PhDStudy ChairM.D. Anderson Cancer Center

Erika Hamilton, MDStudy ChairTennessee Oncology

4 Previous Clinical Trials

458 Total Patients Enrolled

1 Trials studying Breast Cancer

36 Patients Enrolled for Breast Cancer

Media Library

ART4215 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04991480 — Phase 1 & 2

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

Breast Cancer Clinical Trial 2023: ART4215 Highlights & Side Effects. Trial Name: NCT04991480 — Phase 1 & 2

ART4215 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04991480 — Phase 1 & 2

Frequently Asked Questions

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

Across how many different locations is this trial taking place?

"So far, 7 patients have been enrolled in this trial at locations including Yale School of Medicine, Oklahoma University, and University of Pennsylvania/Abramson Cancer Center. There are also 7 other sites where recruitment is ongoing."

Answered by AI

Are there any available openings for participants in this research project?

"The most recent information available on clinicaltrials.gov suggests that this study is still actively recruiting patients. The trial was initially posted on September 13th, 2021 and updated as recently as October 5th, 2022."

Answered by AI

How many individuals are participating in this clinical trial?

"That is correct, the online information hosted on clinicaltrials.gov indicates that this study is looking for more participants. The trial was first posted September 13th 2021 and has since been updated October 5th of this year. They are recruiting a total of 206 patients from 7 different locations."

Answered by AI

Are there case studies of ART4215's success?

"ART4215 was first studied a decade ago at City of Hope. So far, there have been 32 completed studies and 60 more that are ongoing. A significant portion of these live clinical trials are based in New Haven, Connecticut."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors

2021. "A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04991480.

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