Solid TumorsPhase 1NCT05613036

A Study in People With Advanced Cancer to Test How BI 907828 is Processed in the Body

A Phase 1 study testing [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1), [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2) and BI 907828 in people with Solid Tumors, run by Boehringer Ingelheim at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful or no treatment exists can take part. This study tests a medicine called BI 907828. BI 907828 is a so-called p53-MDM2 antagonist that is being developed to treat cancer. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Solid Tumors
What is being tested?: [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1), [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2) and BI 907828
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteHungary
Study dates: 3 Jan 2023to 13 Jan 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Male patients, age 18-70 years; or women of non-childbearing potential* aged ≥ 18 years and ≤ 70 years at the time of signature of the ICF.
Non-childbearing potential is defined as permanently sterile or post-menopausal. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilization. Postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of FSH above 40 U/L or 40 IU/L and estradiol below 30 ng/L or 110.13 pmol/L is confirmatory) without an alternative medical cause.
Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic solid tumor.
Patients with measurable or non-measurable disease. Non-evaluable disease is allowed.
Patient who has failed or rejected conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient should have exhausted available treatment options known to prolong survival for their disease.

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BMI of 18.5 to 29.9 kilogram per square meter (kg/m2) at Screening.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
All toxicities related to previous anti-cancer therapies have resolved ≤ CTCAE Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 and). Note: Patients with chronic grade 2 toxicities that are asymptomatic or adequately managed with stable medication may be eligible with approval from the Sponsor.
Further inclusion criteria apply.

Who cannot join

Patients with known TP53 mutant tumours (Note: testing is not mandatory for inclusion).
Second malignancy currently requiring active therapy (except for hormonal /antihormonal treatment e.g. in prostate or breast cancer).
Received chemo-, immuno-, or molecular-targeted cancer-therapy or investigational drug within the past 30 days or within 5 half-life periods (as far as known for investigational therapies) prior to the initiation of trial treatment or planning to receive any of these therapies concomitantly with this trial. This restriction does not apply to steroids, bisphosphonates, and hormonal/antihormonal treatment (e.g. in prostate or breast cancer).
Patients who have received radiotherapy within 4 weeks prior to trial entry. Note: Patients receiving limited palliative radiation to non-gastrointestinal areas within 4 weeks prior to trial entry may still be eligibility upon discussion with and confirmation from the Sponsor.
No ¹⁴C related study medication containing over 0.1 Megabecquerel (MBq) radiation in the last 12 months prior to dosing in the current study.
Clinical evidence of active brain metastasis or leptomeningeal disease in the past 6 months prior to screening.

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Irregular defecation pattern (less than once per 2 days) or urinary incontinence (applicable for Cohort 1 (ADME) patients only).
Patient is unwilling to undergo intensive blood sampling or has veins unsuitable for blood sampling or infusion.
Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

PRA Hungary Ltd.
Budapest, 1077

Other trials in Hungary

About this study

Official title: An Open-label, Non-randomized Phase I Investigation of Human ADME (Absorption, Distribution, Metabolism and Excretion) and Absolute Oral Bioavailability of BI 907828 in Patients With Advanced Solid Tumours

The purpose of the study is to find out how BI 907828 is processed in the body. In the first 3 weeks, participants therefore get a single dose of BI 907828 in a labelled form. The first participants take BI 907828 as a liquid. This is to find out how much BI 907828 is taken up in the body when it is taken by mouth. Participants who join the study later get BI 907828 as an infusion into a vein in a labelled form and take BI 907828 as a normal tablet. This is to find out how long BI 907828 stays in the blood. After the first 3 weeks, all participants take BI 907828 as tablets every 3 weeks as long as they benefit from treatment and can tolerate it.

During the study, participants visit the study site regularly. Some of the study visits include staying overnight. At the beginning, some of the participants stay at the study site for 15 nights. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions: Solid Tumors
Being tested: [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1), [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2), BI 907828

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1)Drug
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1)
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2)Drug
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2)
BI 907828Drug
Also called Brigimadlin
BI 907828

Study groups in NCT05613036
Study group	Role	What they receive
Cohort 1: Formulation 1 (Cycle 1) then BI 907828 (Cycle 2 onwards)	Experimental	Not described Receives: Drug: [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1); Drug: BI 907828
Cohort 2: BI 907828 (T) then Formulation 2 (R) (Cycle 1) then BI 907828 (Cycle 2 onwards)	Experimental	Not described Receives: Drug: [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2); Drug: BI 907828

What is being measured

The primary outcome is the main question the study is designed to answer.

Cohort 1: fraction of [¹⁴C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point per patient (feurine, 0-tz)
Measured: up to 36 days
Cohort 1: fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point per participant (fefaeces, 0-tz)
Measured: up to 36 days
Cohort 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUCo-∞) for [¹⁴C]-BI 907828
Measured: up to 15 days
Cohort 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUCo-∞) for BI 907828
Measured: up to 15 days

Secondary outcomes (3)

Cohort 1: : Maximum measured concentration-time curve of the analyte ([14C]-radioactivity, BI 907828 and its metabolite) in plasma (Cmax)
Measured: up to 36 days
Cohort 1: Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point (AUC0-tz)
Measured: up to 36 days
Cohort 2: Maximum measured concentration-time curve of the analyte in plasma (Cmax)
Measured: up to 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 202313 Jan 2025

First posted14 Nov 2022
Study start3 Jan 2023
Primary completion25 Apr 2024
Study completion13 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorsStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05613036
Sponsor's protocol ID: 1403-0005
Other IDs: 2021-006682-38
Status last verified: Jan 2025
First submitted: 3 Nov 2022
Last updated: 22 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Non-randomized Phase I Investigation of Human ADME (Absorption, Distribution, Metabolism and Excretion) and Absolute Oral Bioavailability of BI 907828 in Patients With Advanced Solid Tumours
ClinicalTrials.gov ID: NCT05613036
Acronym / sponsor ID: 1403-0005
Conditions: Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 3 Jan 2023 (actual)
Primary completion: 25 Apr 2024 (actual)
Study completion: 13 Jan 2025 (actual)
First posted: 14 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1: Formulation 1 (Cycle 1) then BI 907828 (Cycle 2 onwards)	Experimental	Drug: [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1), Drug: BI 907828
Cohort 2: BI 907828 (T) then Formulation 2 (R) (Cycle 1) then BI 907828 (Cycle 2 onwards)	Experimental	Drug: [¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2), Drug: BI 907828

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Male patients, age 18-70 years; or women of non-childbearing potential* aged ≥ 18 years and ≤ 70 years at the time of signature of the ICF.
Non-childbearing potential is defined as permanently sterile or post-menopausal. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilization. Postmenopausal defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of FSH above 40 U/L or 40 IU/L and estradiol below 30 ng/L or 110.13 pmol/L is confirmatory) without an alternative medical cause.
Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic solid tumor.
Patients with measurable or non-measurable disease. Non-evaluable disease is allowed.

Key exclusion criteria (9 listed)

Patients with known TP53 mutant tumours (Note: testing is not mandatory for inclusion).
Second malignancy currently requiring active therapy (except for hormonal /antihormonal treatment e.g. in prostate or breast cancer).
Received chemo-, immuno-, or molecular-targeted cancer-therapy or investigational drug within the past 30 days or within 5 half-life periods (as far as known for investigational therapies) prior to the initiation of trial treatment or planning to receive any of these therapies concomitantly with this trial. This restriction does not apply to steroids, bisphosphonates, and hormonal/antihormonal treatment (e.g. in prostate or breast cancer).
Patients who have received radiotherapy within 4 weeks prior to trial entry. Note: Patients receiving limited palliative radiation to non-gastrointestinal areas within 4 weeks prior to trial entry may still be eligibility upon discussion with and confirmation from the Sponsor.
No ¹⁴C related study medication containing over 0.1 Megabecquerel (MBq) radiation in the last 12 months prior to dosing in the current study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1)[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 1)	Drug	Cohort 1: Formulation 1 (Cycle 1) then BI 907828 (Cycle 2 onwards)
[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2)[¹⁴C]-BI 907828 mixed with BI 907828 (formulation 2)	Drug	Cohort 2: BI 907828 (T) then Formulation 2 (R) (Cycle 1) then BI 907828 (Cycle 2 onwards)
BI 907828Also: BrigimadlinBI 907828	Drug	Cohort 1: Formulation 1 (Cycle 1) then BI 907828 (Cycle 2 onwards), Cohort 2: BI 907828 (T) then Formulation 2 (R) (Cycle 1) then BI 907828 (Cycle 2 onwards)

Primary outcome

Cohort 1: fraction of [¹⁴C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point per patient (feurine, 0-tz)
Time frame: up to 36 days
Cohort 1: fraction of [14C]-radioactivity excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point per participant (fefaeces, 0-tz)
Time frame: up to 36 days
Cohort 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUCo-∞) for [¹⁴C]-BI 907828
Time frame: up to 15 days
Cohort 2: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity (AUCo-∞) for BI 907828
Time frame: up to 15 days

3 secondary outcomes

Cohort 1: : Maximum measured concentration-time curve of the analyte ([14C]-radioactivity, BI 907828 and its metabolite) in plasma (Cmax)
Time frame: up to 36 days
Cohort 1: Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point (AUC0-tz)
Time frame: up to 36 days
Cohort 2: Maximum measured concentration-time curve of the analyte in plasma (Cmax)
Time frame: up to 15 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: fraction of [¹⁴C]-radioactivity excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point per patient (feurine, 0-tz) (time frame: up to 36 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05613036.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.