NCT05372367

A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor

Completed Phase 1 Last updated 3 February 2026

What this trial tests

Phase 1 trial testing BI 907828 in Solid Tumors in 33 participants. Completed in 29 April 2025.

Timeline

11 August 2022

Primary endpoint
17 July 2024

29 April 2025

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	11 August 2022
Primary completion	17 July 2024
Estimated completion	29 April 2025
Sites	7 locations across Belgium, Spain

Drugs / interventions tested

• BI 907828 — full drug profile →
• Rifampicin (Rifampicin) — full drug profile →
• Itraconazole — full drug profile →

Conditions studied

• Solid Tumors — all drugs for Solid Tumors →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 70, any sex, with Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is open for adults with advanced cancer (solid tumours). This is a study for people for whom previous treatment was not successful.

This study tests a medicine called BI 907828. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. The purpose of this study is to find out whether the amount of BI 907828 in the blood is influenced by taking an OATP inhibitor or a CYP3 inhibitor. This study uses an OATP inhibitor called rifampicin and a CYP3 inhibitor called itraconazole. In clinical practice, rifampicin is used as an antibiotic. Itraconazole is used to treat fungal infections.

Participants are divided into 2 groups: a rifampicin group and an itraconazole group. Every participant takes BI 907828 as a tablet every 3 weeks. This is called a cycle.

* Rifampicin group: In addition to BI 907828, participants take 1 tablet of rifampicin in the second cycle.
* Itraconazole group: In addition to BI 907828, participants take itraconazole tablets for 20 days starting 1 week after the second cycle begins

Participants can stay in the study as long as they benefit from treatment and can tolerate it.

The doctors take blood samples from the participants to compare the amount of BI 907828 in the blood when it is taken alone and when participants also take rifampicin. Doctors also regularly check participants' health and take note of any unwanted effects.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting p53 pathways: mechanisms, structures, and advances in therapy.
   Wang H, Guo M, Wei H, Chen Y. · · 2023 · cited 580× · PMID 36859359 · DOI 10.1038/s41392-023-01347-1
2. MDM2 Inhibitors for Cancer Therapy: The Past, Present, and Future.
   Wang W, Albadari N, Du Y, Fowler JF, et al · · 2024 · cited 85× · PMID 38697854 · DOI 10.1124/pharmrev.123.001026
3. Highlights on U.S. FDA-approved fluorinated drugs over the past five years (2018-2022).
   Ali S, Zhou J. · · 2023 · cited 56× · PMID 37207534 · DOI 10.1016/j.ejmech.2023.115476
4. Therapeutic Strategies to Activate p53.
   Aguilar A, Wang S. · · 2022 · cited 20× · PMID 36678521 · DOI 10.3390/ph16010024
5. Highlights on Fluorine-containing Drugs Approved by U.S. FDA in 2023.
   Ali S, Bolinger AA, Zhou J. · · 2024 · cited 15× · PMID 38445700 · DOI 10.2174/0115680266300245240223070242
6. Targeting MDM2, RAS, and PCNA for cancer targeted therapy: pan-cancer approaches vs. cancer-specific strategies.
   Wang W, Alley A, Sun N, Tadesse M, et al · · 2025 · PMID 41170373 · DOI 10.3389/fphar.2025.1663766