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

Part of paid clinical trials in Irving, Texas.

Sponsor
AIMEDBIO
Study ID
NCT07827144
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI 4060107 — BIOLOGICAL
    BI 4060107

Study Details

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.

Key Dates

First listed
Sep 18, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
May 13, 2030
Completion
May 13, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: BI 4060107 dose level 1
  • Experimental: Cohort 2: BI 4060107 dose level 2
  • Experimental: Cohort 3: BI 4060107 dose level 3
  • Experimental: Cohort 4: BI 4060107 dose level 4
  • Experimental: Cohort 5: BI 4060107 dose level 5

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Oncology - IrvingIrvingTexas75039
Boehringer Ingelheim
[email protected]
18336022368

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By research site
Texas Oncology - Irving· Irving, TX

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