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Monoclonal Antibodies

BDTX-1535 for Brain Tumor

Q: What objectives are being pursued with this clinical investigation?

<p>During this Phase 0 Intraoperative Sample duration, the primary objective is to measure total concentration of BDTX-1535 in tumor tissue. Secondary goals include ascertaining Percentage of pEGFR positive cells in tumor tissue, Percentage of pERK positive cells in tumour tissue, and Median Overall Survival in patients with demonstrated Pharmacokinetics effects.</p>

Q: Are there any open slots available for applicants in this investigation?

<p>According to the clinicaltrials.gov portal, this trial is no longer recruiting participants; its initial posting was on October 27th 2023 and it has not been updated since then. However, there are other 371 studies that remain open for enrollment presently.</p>

Phase < 1

Recruiting

Led By Nader Sanai, MD

Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix

Eligibility Criteria Checklist

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

Must have

Participants who have had a prior resection of diagnosed HGG (2021 WHO grade 3 and 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy.

Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will test a new drug to see if it can safely treat people with tumors reliant on a certain growth signal due to gene changes.

Who is the study for?

This trial is for patients with recurrent high-grade glioma brain tumors that have progressed after standard treatments, including surgery, temozolomide chemotherapy, and radiotherapy. Participants must have specific EGFR gene changes in their tumors and be able to swallow pills. They should be relatively stable physically (ECOG PS ≤2) and not have severe cardiovascular disease, active infections or liver disease.Check my eligibility

What is being tested?

BDTX-1535 is being tested in this study. It's a new drug aimed at blocking a growth signal in cancers linked to certain EGFR protein alterations found only in the tumors. The goal is to see if it can safely help people whose tumors depend on this signal due to these genetic changes.See study design

What are the potential side effects?

While the exact side effects of BDTX-1535 are not listed here, similar drugs often cause issues like fatigue, skin reactions, diarrhea, mouth sores and potential allergic reactions. Patients will be monitored closely for any adverse effects related to organ function.

Eligibility Criteria

Inclusion Criteria

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

Select...

I had surgery for a high-grade glioma and have received standard treatments but my cancer has progressed.

Select...

I can perform all self-care but cannot work.

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I can swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Progression Free Survival (PFS)

Total concentration of BDTX-1535 in tumor tissue

Unbound concentration of BDTX-1535 in tumor tissue

Secondary outcome measures

Clinical laboratory abnormalities per CTCAE

Concentration of BDTX-1535 in CSF

Overall survival (OS)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Recurrent high-grade glioma participants with EGFR fusionExperimental Treatment1 Intervention

Group II: Recurrent high-grade glioma participants with EGFR alterationsExperimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor

63 Previous Clinical Trials

14,595 Total Patients Enrolled

Ivy Brain Tumor CenterOTHER

10 Previous Clinical Trials

355 Total Patients Enrolled

Barrow Neurological InstituteOTHER

24 Previous Clinical Trials

7,041 Total Patients Enrolled

Frequently Asked Questions

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

What objectives are being pursued with this clinical investigation?

"During this Phase 0 Intraoperative Sample duration, the primary objective is to measure total concentration of BDTX-1535 in tumor tissue. Secondary goals include ascertaining Percentage of pEGFR positive cells in tumor tissue, Percentage of pERK positive cells in tumour tissue, and Median Overall Survival in patients with demonstrated Pharmacokinetics effects."

Answered by AI

Are there any open slots available for applicants in this investigation?

"According to the clinicaltrials.gov portal, this trial is no longer recruiting participants; its initial posting was on October 27th 2023 and it has not been updated since then. However, there are other 371 studies that remain open for enrollment presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions

2023. "Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06072586.