Brigimadlin + Radiation for Glioblastoma

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests BI 907828, a new drug for treating brain tumors. It targets adults with newly diagnosed glioblastoma. The drug works by blocking a protein that helps cancer cells grow. The study aims to see how well the drug is absorbed in the tumor and find the highest safe dose when combined with radiation therapy.

Research Team

Eligibility Criteria

Adults with newly diagnosed glioblastoma, a type of brain tumor. Part 1 is for those awaiting surgery; Part 2 for post-surgery patients eligible for radiation therapy. Must be over 18, have good performance status (0 or 1), and stable health on certain medications. Excludes those with specific genetic mutations, prior systemic therapy/radiotherapy (except Phase 0 participants), poor kidney function, or incompatible implants.

Inclusion Criteria

I am a candidate for surgery to remove a brain tumor.

I had surgery to remove a brain tumor and can have standard radiotherapy.

My glioblastoma is TP53 wild type and has unmethylated MGMT promoters.

Exclusion Criteria

My grade IV astrocytoma is IDH mutant.

I have had treatment for glioblastoma, but not in a Phase 0 trial.

I cannot have an MRI due to kidney issues or metal implants.

Treatment Details

Interventions

• BI 907828 (MDM2 Inhibitor)
• Radiation Therapy (Radiation)

Trial Overview The study tests BI 907828 (Brigimadlin), an MDM2 inhibitor cancer drug. Part 1 assesses how the drug accumulates in the tumor after one dose before surgery. In Part 2, the highest tolerable dose is sought alongside standard radiation therapy over six weeks with regular visits and potential continuation if beneficial.

Participant Groups

Group I: Phase Ia Part: BI 907828 (Brigimadlin) Experimental Treatment 1 Intervention

Group II: Phase 0 Part: BI 907828 (Brigimadlin) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+