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.

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

My diagnosis of glioblastoma was confirmed through a biopsy or imaging tests.

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

I am 18 years old or older.

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

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

I have been diagnosed with glioblastoma through a biopsy or imaging tests.

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

I am 18 years old or older.

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

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

Exclusion Criteria

I must take or plan to take certain restricted medications.

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

I am not taking any medication that could interfere with the trial.

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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Phase Ia Part: BI 907828 (Brigimadlin)Experimental Treatment1 Intervention

Group II: Phase 0 Part: BI 907828 (Brigimadlin)Experimental Treatment1 Intervention