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MDM2 Inhibitor

BI 907828 for Advanced Cancer

Phase 1
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are not eligible to receive standard of care treatments, and for whom no proven treatments exist
Patient has a tumor with either a known TP53 wild type status, or unknown TP53 status, and regardless of MDM2 amplification status, at the time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, BI 907828, to see if it's effective and safe. Participants will take BI 907828 either once every three weeks or twice every four weeks, depending on how well they tolerate the drug. The goal is to see if BI 907828 causes tumors to shrink.

Who is the study for?
Adults with various advanced solid tumors who have progressed after prior treatments or have no standard treatment options can join. They must be willing to provide tissue samples and undergo regular health checks. Those with specific genetic tumor profiles (TP53 wild type, MDM2-amplified) are eligible for certain study phases.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a new cancer drug called BI 907828 (brigimadlin), an MDM2 inhibitor taken as a tablet. It aims to determine the best dose that shrinks tumors, given either once every three weeks or twice every four weeks.See study design
What are the potential side effects?
As this is the first time brigimadlin is given to humans, side effects are not yet fully known but may include typical reactions related to cancer medications such as nausea, fatigue, blood count changes, and potential organ-specific toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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No standard treatments are suitable or available for my condition.
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My tumor is either TP53 wild type or its TP53 status is unknown.
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My sarcoma is TP53 wild type and MDM2-amplified, and it has spread.
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My cancer is confirmed and has spread from where it started.
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My cancer has grown or returned after treatment.
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I am willing to have a tumor biopsy and blood tests for study purposes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Phase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B)
Phase Ia- Maximum tolerated dose (MTD) based on number of patients with dose limiting toxicities (DLTs) during first treatment cycle
Phase Ib - Number of patients with DLTs during the first treatment cycle
+1 more
Secondary outcome measures
Phase Ia - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
Phase Ia - Cmax: Maximum measured concentration of BI 907828 in plasma
Phase Ib - AUC0-∞: Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Group II: Dose EscalationExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,498 Previous Clinical Trials
11,339,474 Total Patients Enrolled
3 Trials studying Tumors
1,624 Patients Enrolled for Tumors

Media Library

BI 907828 (MDM2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03449381 — Phase 1
Tumors Research Study Groups: Dose Escalation, Dose Expansion

Frequently Asked Questions

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

Has BI 907828 received ratification from the FDA?

"Due to the limited data available on BI 907828, our team at Power has assigned it a score of 1 out of 3 in regards to safety as this is an early phase trial."

Answered by AI

How many health care facilities are conducting this experiment?

"Participants in this medical study will be seen at Memorial Sloan-Kettering Cancer Center, The Ottawa Hospital and Yale University School of Medicine. Additionally, 6 other clinical trial sites are operational for the duration of this research project."

Answered by AI

How many individuals are being recruited for participation in this experiment?

"This medical trial is looking for a total of 204 participants that meet the pre-determined criteria. It will be administrated by Boehringer Ingelheim from multiple sites, such as Memorial Sloan-Kettering Cancer Center in New york and The Ottawa Hospital in Ontario."

Answered by AI

Are researchers still accepting participants for this research endeavor?

"Affirmative. Clinicaltrials.gov records show that this clinical trial, which initially opened on May 21st 2018, is actively accepting participants. 204 patients need to be enlisted from 6 different medical sites."

Answered by AI
~69 spots leftby Mar 2026