A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study of BI 907828 in Patients With Advanced or Metastatic Solid Tumors

  • STATUS
    Recruiting
  • End date
    Apr 30, 2026
  • participants needed
    204
  • sponsor
    Boehringer Ingelheim
Updated on 28 October 2022
measurable disease
TP53
advanced cancer
primary cancer
solid neoplasm
sarcoma

Summary

This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 the participants can tolerate. The most suitable dose is used in the second part to find out whether BI 907828 makes tumors shrink.

In this study, BI 907828 is given to humans for the first time. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. BI 907828 is taken as a tablet. Participants either take a dose of BI 907828 on one day every 3 weeks or on two days every 4 weeks.

The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.

Details
Condition Neoplasms
Treatment BI 907828
Clinical Study IdentifierNCT03449381
SponsorBoehringer Ingelheim
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of signed and dated, written informed consent form ICF in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses
Pathologically documented, advanced solid tumors
Patients fulfilling one or more of the following criteria
Radiologically documented disease progression or relapse
Phase Ia (dose escalation) only
Patients who are not eligible to receive standard of care treatments, and for whom no proven treatments exist
Patients with MDM2 amplified sarcomas who require first line treatment (for Ph Ib/dose expansion - Cohort 1 only)
Patients with MDM2 amplified sarcomas may fulfil any one of the above three criteria
to be considered eligible
Phase Ib (expansion phase) only
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
Phase Ia (dose escalation) only
Cohort 1: TP53 wt and MDM2-amplified sarcoma with advanced/metastatic disease at any line of therapy. If TP53 status is not available during screening, the patient may be included with unknown TP53 status if a tissue sample is submitted for central laboratory assessment. If TP53 status cannot be evaluated, the patient may be included if agreed between the Investigator and Sponsor
Patient with either measurable or non-measurable disease
Cohort 2: TP53 wt and MDM2- amplified NSCLC, urothelial, gastric, biliary tract (including cholangiocarcinoma, intra- and extrahepatic biliary tree, gall blander and ampulla of vater) or pancreatic solidPDAC tumors who have had at least one previous line of therapy for advanced/metastatic disease. If TP53 status cannot be evaluated the patient may be included if agreed between the Investigator and Sponsor
Non-evaluable disease allowed
Phase Ib (expansion phase) only
At least one target lesion that can be accurately measured per RECIST v.1.1
Phase Ia
Patient must be willing to undergo blood sampling for PK, pharmacodynamic, biomarker, and PGx analyses
Phase Ib
Patient must be willing to undergo tumor biopsy sampling for pharmacodynamic analyses and blood sampling for PK, pharmacodynamics, and biomarker analyses
Willingness to provide a fresh tumor tissue sample obtained after relapse/ progression during or after prior therapy. In case a fresh biopsy cannot be obtained (e.g. inaccessible lesions or patient safety concern), an archived specimen, collected before screening within 12 months of enrollment, may be submitted. If these requirements cannot be met, then the patient may be allowed to enter the study at Sponsor discretion, after agreement between the Investigator and Sponsor
Further inclusion criteria apply

Exclusion Criteria

Previous administration of BI 907828 or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist
Known TP53 mutant tumor
Symptomatic metastases from non-brain tumors. Note: Patients with previously treated brain metastases may participate provided they are stable, without evidence of progression by imaging (using the identical imaging modality for each assessment, either MRI or computed tomography (CT) scan), for at least four weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline; have no evidence of new or enlarging brain metastases. Patients on corticosteroids must have a stable dose for at least 5 days prior to baseline MRI
Patients with history of bleeding diathesis
Major surgery (major according to the Investigator's assessment) performed within 12 weeks prior to start of study treatment, or planned within 12 months after screening (e.g. hip replacement)
Any other documented active or suspected malignancy or history of malignancy within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Further exclusion criteria apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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