BDTX-1535 for Brain Tumor

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byNader Sanai, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

Must not be taking: Prohibited medications

Disqualifiers: Pregnancy, Liver disease, Cardiovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will administer the investigational drug, BDTX-1535 to eligible patients with recurrent high-grade glioma. BDTX-1535 was designed to block a growth signal important to some cancers. BDTX-1535 is being tested in this study to see if it can be given safely to people who have tumors that can be dependent on that growth signal because of changes in a protein called EGFR. These gene changes are called amplifications, mutations, fusions or alterations and are found only in the tumors.

Will I have to stop taking my current medications?

The trial mentions that some medications are prohibited, but it doesn't specify which ones. You may need to stop certain medications, so it's best to discuss your current medications with the trial team.

Research Team

Nader Sanai, MD

Principal Investigator

Chief Scientific Officer/Director of the Ivy Brain Tumor Center

Eligibility Criteria

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.

Inclusion Criteria

My bone marrow and organs are functioning well.

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

I can perform all self-care but cannot work.

See 3 more

Exclusion Criteria

I have a serious heart condition.

I do not have severe infections or serious liver diseases.

I have symptoms or imaging results showing disease in the lining of my brain or spinal cord.

See 5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 0

Participants receive BDTX-1535 prior to planned resection; samples collected during surgery

1 week

1 visit (in-person, surgical)

Treatment

Participants with PK response continue with once-daily BDTX-1535 in 28-day cycles

Continuous 28-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

Treatment Details

Interventions

BDTX-1535 (Monoclonal Antibodies)

Trial OverviewBDTX-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.

Participant Groups

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