BI 765049 for Colorectal and Pancreatic Cancer

Recruiting at 6 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

Trial Summary

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.

What makes the drug BI 765049 unique for treating colorectal and pancreatic cancer?

The drug BI 765049 is unique because it represents a novel approach to treating colorectal and pancreatic cancer, potentially offering a new mechanism of action compared to traditional chemotherapy regimens. While existing treatments often involve combinations of chemotherapy drugs like 5-FU, leucovorin, and oxaliplatin, BI 765049 may provide an alternative for patients, especially if it targets cancer cells differently or offers a different administration route or schedule. ^{1 2 3 4 5}

What is the purpose of this trial?

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. People can take part in this study if their previous treatment was not successful, or no other treatment exists. 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 most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer. Participants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment but no longer than 3 years. During this time, participants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within 1 week after the first treatment with the intended dose.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Pakistan 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. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Clinical overview: adjuvant therapy of gastrointestinal cancer. [2005]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Combined surgery for locally advanced colorectal cancer]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Bayesian Approach to Understand the Association Between Treatment Down-staging and Survival for Patients With Pancreatic Adenocarcinoma. [2023]