BI 765179 for Tumors

Istituto Nazionale IRCCS Tumori Fondazione Pascale, Napoli, Italy
TumorsBI 765179 - Drug
Eligibility
18+
All Sexes

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective. People with advanced cancer who have not had success with other treatments are eligible to participate. The treatment consists of a new medication, BI 765179, given alone or with another medication, ezabenlimab. The study will last up to three years, and participants will be closely monitored for any side effects.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: up to 36 months

Day 21
Area under the concentration-time curve of BI 765179 in plasma over a uniform dosing interval from zero to 504h (AUC0-504)
Area under the concentration-time curve of BI 765179 or ezabenlimab in plasma over a uniform dosing interval from zero to 504h (AUC0-504)
Maximum Tolerated Dose (MTD)
Maximum measured concentration of BI 765179 in plasma (Cmax)
Maximum measured concentration of BI 765179 or ezabenlimab in plasma (Cmax)
Number of patients experiencing Dose Limiting Toxicities (DLTs) in the MTD evaluation period
Day 84
Area under the concentration-time curve of BI 765179 in plasma at steady state over a uniform dosing interval 504h (AUC0-504,ss)
Area under the concentration-time curve of BI 765179 or ezabenlimab in plasma at steady state over a uniform dosing interval 504h (AUC0-504,ss)
up to 36 months
Number of patients experiencing DLTs during the on-treatment period (per arm)
Day 84
Maximum measured concentration of BI 765179 in plasma at steady state (Cmax,ss)
Maximum measured concentration of BI 765179 or ezabenlimab in plasma at steady state (Cmax,ss)

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm A: BI 765179
1 of 2
Arm B: BI 765179 + ezabenlimab
1 of 2

Experimental Treatment

160 Total Participants · 2 Treatment Groups

Primary Treatment: BI 765179 · No Placebo Group · Phase 1

Arm A: BI 765179
Drug
Experimental Group · 1 Intervention: BI 765179 · Intervention Types: Drug
Arm B: BI 765179 + ezabenlimabExperimental Group · 2 Interventions: Ezabenlimab, BI 765179 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,422 Previous Clinical Trials
10,238,699 Total Patients Enrolled
3 Trials studying Tumors
1,624 Patients Enrolled for Tumors

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of cancer that has spread and cannot be removed by surgery. You have already tried standard treatments, but they did not work or are not suitable for you.

Frequently Asked Questions

What is the total enrollment of this research project?

"Affirmative. The information on clinicaltrials.gov verifies that this investigation is currently enrolling patients and was initially published on September 24th 2021. 150 individuals need to be recruited across 2 sites, with a recent update done November 2nd 2022." - Anonymous Online Contributor

Unverified Answer

Are recruitment efforts currently underway for this investigation?

"That's accurate. According to clinicaltrials.gov, this medical experiment began recruiting on September 24th 2021 and is still taking applications today as per its last update from November 2nd 2022. 150 volunteers are necessary for the project at two separate sites of study." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned BI 765179 for public use?

"Due to its early stage status, BI 765179's safety can only be estimated at a score of 1. There is limited data available in terms of efficacy and overall security for this drug candidate." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.