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

NCT07827144 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 2035-0001
• Study Type: interventional
• Target: 90
• Locations: 5 countries
• Sites: 6

Brief Summary

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.

Conditions

Solid Tumours

Outcome Measures

Primary Outcomes (1)

• Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period

  up to 21 days

Secondary Outcomes (14)

• Occurrence of adverse events (AEs) during the on-treatment period

  up to 36 months

• Occurrence of AE fulfilling DLT criteria during the on-treatment period

  up to 36 months

• Maximum measured concentration (Cmax) of pharmacokinetic (PK) parameters of BI 4060107

  up to 4 days per cycle

• Cmax of analyte I

  up to 4 days per cycle

• Cmax of analyte II

  up to 4 days per cycle

Study Arms (5)

Cohort 1: BI 4060107 dose level 1

EXPERIMENTAL

Biological: BI 4060107

Cohort 2: BI 4060107 dose level 2

EXPERIMENTAL

Biological: BI 4060107

Cohort 3: BI 4060107 dose level 3

EXPERIMENTAL

Biological: BI 4060107

Cohort 4: BI 4060107 dose level 4

EXPERIMENTAL

Biological: BI 4060107

Cohort 5: BI 4060107 dose level 5

EXPERIMENTAL

Biological: BI 4060107

Interventions

BI 4060107 BIOLOGICAL

BI 4060107

Cohort 1: BI 4060107 dose level 1; Cohort 2: BI 4060107 dose level 2; Cohort 3: BI 4060107 dose level 3; Cohort 4: BI 4060107 dose level 4; Cohort 5: BI 4060107 dose level 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• Patients with histologically or cytologically confirmed diagnosis of an unresectable advanced and/or metastatic or relapsed/refractory solid tumour.
• 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.

You may not qualify if:

• Patients who have previously received an agent with the same target as the investigational medicinal product (IMP)
• 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
• Current enrolment in another investigational device or drug trial

Sponsors & Collaborators

• AIMEDBIO: lead
• Boehringer Ingelheim: collaborator

Study Sites (6)

Texas Oncology - Irving

Irving, Texas, 75039, United States

Location

Austin Health

Heidelberg, Victoria, 3048, Australia

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

National Cancer Center Hospital

Tokyo, Chuo-ku, 104-0045, Japan

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Central Study Contacts

Boehringer Ingelheim

CONTACT

18002430127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are enrolled into 5 successive cohorts receiving increasing dose levels. Additional participants may be enrolled at doses considered safe to further evaluate safety and tolerability.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): May 13, 2030
• Study Completion (Estimated): May 13, 2030
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); KR (2); US (1); AU (1); FR (1)