BI 765049 for Colorectal and Pancreatic Cancer

Recruiting at 13 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: Anticoagulants

Disqualifiers: Major surgery, Other malignancies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 36 months

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 765049 (experimental treatment), to evaluate its effectiveness for individuals with advanced colon, rectum, stomach, or pancreatic cancer that is inoperable or has metastasized. The main goal is to determine the highest tolerable dose and the optimal administration method. Participants will receive this treatment at least once every three weeks and must visit the study site for health check-ups and lab tests. Individuals with these cancers, whose previous treatments have failed, might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulant treatment that cannot be safely interrupted, you may not be eligible to participate.

Is there any evidence suggesting that BI 765049 is likely to be safe for humans?

Research has shown that BI 765049 is being tested to assess its tolerability in people with advanced cancers, such as colorectal and pancreatic cancer. Scientists aim to determine the highest dose that can be administered safely without causing serious health issues. This is crucial because higher doses might be more effective against cancer, but they must also remain safe.

Currently, detailed information about specific side effects or their frequency is unavailable. As this is an early study, researchers are still determining the optimal dose and are closely monitoring for any problems. Study participants receive careful monitoring, and doctors watch for any unwanted effects linked to the treatment.

BI 765049 aids the immune system in fighting cancer. Since it is still under study, understanding its tolerability is a key research focus. For now, scientists concentrate on ensuring the treatment's safety at various doses. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal and pancreatic cancer?

Most treatments for colorectal and pancreatic cancer, like chemotherapy and targeted therapies, work by attacking rapidly dividing cells or specific cancer cell markers. But BI 765049 works differently, targeting a unique pathway involved in immune response modulation. Researchers are excited about this treatment because it harnesses the body's own immune system to fight the cancer, potentially offering a new way to tackle tumors that don't respond well to traditional therapies. Additionally, this approach might lead to fewer side effects compared to conventional treatments, making it a promising option for patients.

What evidence suggests that BI 765049 might be an effective treatment for advanced colorectal and pancreatic cancer?

Research shows that BI 765049, which participants in this trial may receive, might help the immune system fight cancer. This treatment targets a protein called B7-H6, found in many cancers. Studies have found this protein in 98% of colorectal cancer, 77% of stomach cancer, and 63% of pancreatic cancer samples. BI 765049 is designed to activate T-cells, crucial for the immune system, to attack these cancer cells. Early evidence suggests that targeting B7-H6 could offer a promising new approach to treating these types of cancers. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults with advanced, inoperable or metastatic colon, rectum, stomach, or pancreatic cancer can join this trial if previous treatments failed or no other options exist. They must understand the study and agree to its procedures by signing a consent form.

Inclusion Criteria

I have signed the consent form for this study.

I have been diagnosed with CRC, GC, or PDAC.

I have a confirmed diagnosis of colorectal cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 765049 at least once every 3 weeks to determine the maximum tolerated dose and the recommended phase 2 dose

up to 36 months

Regular visits with several overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 765049

Trial Overview The trial is testing different doses of BI 765049 to find the highest tolerable amount for patients with certain advanced cancers. It also seeks the best dose and administration method for future studies. Treatment occurs at least every three weeks up to three years.

How Is the Trial Designed?

Group I: Part 2 (Administration Regimen B) Experimental Treatment 1 Intervention

Group II: Part 1 (Administration Regimen A) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

In two major clinical trials (PRODIGE 24/CCTG PA.6 and PREOPANC-1), experimental drug regimens for patients with resectable pancreatic adenocarcinomas were associated with increased overall survival rates.

These promising results suggest that the new treatment approaches could lead to changes in clinical practice for managing pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Survival Seen for Some with Pancreatic Cancer. [2019]

In a study of 87 patients with advanced pancreatic cancer, the FOLFIRINOX chemotherapy regimen showed the highest objective response rate (15%) and disease control rate (26%), outperforming gemcitabine and capecitabine regimens.

Patients with locally advanced pancreatic cancer had a median progression-free survival of 39 weeks, significantly longer than the 25 weeks for those with metastatic pancreatic cancer, suggesting that FOLFIRINOX may be a preferred first-line treatment in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Chemotherapy for Locally Advanced and Metastatic Pancreatic Cancer: A Real-life Experience and Outcome from a Tertiary Care Centre. Yasmeen, S., Arshad, F., Shaukat, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06882746

NCT06882746 | A Study to Test Different Doses of BI ... The study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the ...

2. medinfo.boehringer-ingelheim.com medinfo.boehringer-ingelheim.com/us/sites/default/files/2022-11/ph1%20trial%20of%20bi%20765049%20%20bi%20754091%20in%20patients%20with%20advanced%20solid%20tumors%20expressing%20b7-h6.pdf

A first-in-human Phase I dose-escalation trial of the B7-H6/ ... dose-escalation trial of BI 765049 ± ezabenlimab in patients with advanced CRC or other B7-H6-positive tumors. • The primary objective is to determine the.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9713360/

A Novel B7-H6–Targeted IgG-Like T Cell–Engaging ... Results: B7-H6 expression was detected in 98% of colorectal cancer, 77% of gastric cancer, and 63% of pancreatic cancer tissue samples.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04752215

NCT04752215 | A Study Evaluating Different Doses of BI ... The purpose of this study is to find out the highest dose of BI 765049 alone and in combination with ezabenlimab the participants can tolerate.

5. withpower.com withpower.com/trial/phase-1-carcinoma-3-2025-dc44f

BI 765049 for Colorectal and Pancreatic Cancer This study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS2669

A phase Ia/Ib, non-randomized, open-label, dose ... BI 765049 is a novel immunoglobulin G (IgG)-like T-cell engager designed to simultaneously bind B7-H6-expressing tumor cells and CD3 on T-cells.