86 Participants NeededMy employer runs this trial

BI 4060107 for Cancer

Recruiting at 5 trial locations
BI
Overseen ByBoehringer Ingelheim
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called BI 4060107, an experimental therapy for individuals with advanced solid tumors that cannot be surgically removed. The study aims to determine the highest dose patients can tolerate without serious side effects. Participants receive different doses, starting with the lowest, to assess the body's tolerance. This trial targets those who have exhausted all other treatment options. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic anti-cancer therapy or investigational drugs at least 28 days before starting the trial medication. If you are on such treatments, you will need to stop them before joining this study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

In early research, BI 4060107 showed promise for treating tumors and was generally safe in lab tests, indicating good tolerance in laboratory settings. However, since this trial marks the first use of BI 4060107 in humans, careful attention to safety is necessary.

In similar studies with treatments like BI 4060107, common side effects included fever, nausea, and infections, while more serious issues sometimes involved low blood counts or liver problems. In this trial, researchers administer BI 4060107 in closely monitored doses, starting low and increasing only if participants tolerate it well. This approach aims to maintain safety for all participants.12345

Why do researchers think this study treatment might be promising?

Unlike traditional cancer treatments like chemotherapy and radiation, which often target rapidly dividing cells indiscriminately, BI 4060107 is unique because it specifically targets cancer cells, potentially minimizing damage to healthy cells. Researchers are particularly excited about BI 4060107's novel mechanism of action, which involves inhibiting a specific pathway critical for cancer cell survival and growth. This tailored approach not only promises to be more effective but also aims to reduce the side effects typically associated with standard cancer therapies.

What evidence suggests that BI 4060107 might be an effective treatment for advanced cancer?

Research has shown that BI 4060107 could be a promising treatment for advanced cancers. This medicine combines an antibody and a drug, designed to target and kill cancer cells more effectively. It aims to deliver the drug directly to cancer cells, potentially protecting healthy cells and reducing side effects. Early lab studies suggest that this targeted approach focuses more on cancer cells than normal tissue, allowing for more precise attacks on cancer cells. Although human studies have provided limited information, this method shows potential for treating solid tumors that cannot be surgically removed.678910

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that cannot be removed by surgery and who have tried all other available treatments without success. Participants must have no remaining standard treatment options.

Inclusion Criteria

Signed and dated written main informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
I am at least 18 years old and legally able to give consent.
I have no standard treatment options left for my condition.
See 2 more

Exclusion Criteria

Current enrolment in another investigational device or drug trial
I understand there may be other reasons I cannot join this study.
I have not had any experimental cancer treatments in the past month.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 4060107 in dose-escalation cohorts to determine the maximum tolerated dose

Up to 36 months
Regular visits, including overnight stay after first treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BI 4060107

Trial Overview

The study tests different doses of a new medicine called BI 4060107 to find the highest dose people can safely tolerate. Participants are grouped by dose level, starting low and increasing if tolerated. The drug is being given to humans for the first time.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Cohort 5: BI 4060107 dose level 5Experimental Treatment1 Intervention
Group II: Cohort 4: BI 4060107 dose level 4Experimental Treatment1 Intervention
Group III: Cohort 3: BI 4060107 dose level 3Experimental Treatment1 Intervention
Group IV: Cohort 2: BI 4060107 dose level 2Experimental Treatment1 Intervention
Group V: Cohort 1: BI 4060107 dose level 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AIMEDBIO

Lead Sponsor

Boehringer Ingelheim

Industry Sponsor

Trials
2,566
Recruited
16,150,000+

Citations

Boehringer Ingelheim GmbH – Oncology Deals and ...

Boehringer Ingelheim is a research-driven company operating worldwide under two divisions: Human Pharmaceuticals and Animal Healthcare.

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Boehringer and AimedBio partner to develop novel antibody-drug conjugate therapy aiming to transform the treatment landscape for a broad range of cancers.

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Boehringer and AimedBio partner to develop novel antibody-drug conjugate therapy aiming to transform the treatment landscape for a broad range of cancers.

Study Details | BIPI Medical & Clinical Resources

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025 (BI 4060107), an antibody-drug. The trial aims to evaluate the safety, tolerability, and pharmacokinetics of intravenously

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Preclinical studies demonstrated antitumor activity and a favorable safety profile. human study is designed to evaluate the safety, ...