A Study to Test How Well Different Doses of BI 4060107 Are Tolerated by People With Advanced Cancer (Solid Tumours)

September 14, 2026 updated by: AIMEDBIO

A First-in-human Phase I, Open-label, Multicentre Trial of i.v. Administrations of BI 4060107 in Patients With Unresectable Advanced and/or Metastatic Solid Tumours

This study is open to adults with advanced cancer who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. The purpose of this study is to find the highest dose of a medicine called BI 4060107 that people with advanced cancer can tolerate. In this study, BI 4060107 is given to humans for the first time.

Participants are divided into different dose groups based on when they join the study. Each participant within a dose group receives the same dose, with the lowest dose given to the first group. The next group receives a higher dose if the lower dose is tolerated.

Participants can stay in the study for up to 3 years if they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. After the first treatment, participants stay overnight for 1 night at the study site. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 4060107.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. A patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the Informed Consent Forms (ICFs)
  2. Signed and dated written main informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  3. Patients with histologically or cytologically confirmed diagnosis of an unresectable advanced and/or metastatic or relapsed/refractory solid tumour.
  4. Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. The patient must have exhausted available treatment options as per local recommendations and reimbursement policies.
  5. Further inclusion criteria apply

Exclusion Criteria:

  1. Patients who have previously received an agent with the same target as the investigational medicinal product (IMP)
  2. Treatment with a systemic anti-cancer therapy, an investigational device or an investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first administration of trial medication
  3. Radiotherapy within 28 days prior to first administration of trial medication except for palliative radiotherapy to regions other than the chest, or radiotherapy for brain metastases as described under the inclusion criteria in the protocol, is allowed if completed at least 14 days prior to first administration of trial medication
  4. Current enrolment in another investigational device or drug trial
  5. Further exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: BI 4060107 dose level 1
Biological: BI 4060107
BI 4060107
Experimental: Cohort 2: BI 4060107 dose level 2
Biological: BI 4060107
BI 4060107
Experimental: Cohort 3: BI 4060107 dose level 3
Biological: BI 4060107
BI 4060107
Experimental: Cohort 4: BI 4060107 dose level 4
Biological: BI 4060107
BI 4060107
Experimental: Cohort 5: BI 4060107 dose level 5
Biological: BI 4060107
BI 4060107

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period
Time Frame: up to 21 days
up to 21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events (AEs) during the on-treatment period
Time Frame: up to 36 months
up to 36 months
Occurrence of AE fulfilling DLT criteria during the on-treatment period
Time Frame: up to 36 months
up to 36 months
Maximum measured concentration (Cmax) of pharmacokinetic (PK) parameters of BI 4060107
Time Frame: up to 4 days per cycle
(duration of a treatment cycle is 21 days; maximum treatment duration is 36 months)
up to 4 days per cycle
Cmax of analyte I
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Cmax of analyte II
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Cmax of analyte III
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Area under the concentration-time curve of PK parameters of BI 4060107 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Area under the concentration-time curve of analyte I over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Area under the concentration-time curve of analyte II over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Area under the concentration-time curve of analyte III over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Area under the concentration-time curve of PK parameters of BI 4060107 over the dosing interval τ (AUCτ)
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Area under the concentration-time curve of analyte I over the dosing interval τ (AUCτ)
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Area under the concentration-time curve of analyte II over the dosing interval τ (AUCτ)
Time Frame: up to 4 days per cycle
up to 4 days per cycle
Area under the concentration-time curve of analyte III over the dosing interval τ (AUCτ)
Time Frame: up to 4 days per cycle
up to 4 days per cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIMEDBIO

Collaborators

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

May 13, 2030

Study Completion (Estimated)

May 13, 2030

Study Registration Dates

First Submitted

September 14, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2035-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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