Your session is about to expire
← Back to Search
Checkpoint Inhibitor
BI 770371 + Ezabenlimab for Advanced Solid Tumors
Phase 1
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Score: 0 to 1
Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is for adults with advanced cancer who have no other treatment options. The purpose is to find the highest dose of BI 770371 that people can tolerate when taken alone or with ezabenlimab.
Who is the study for?
Adults with advanced solid tumors who have not had success with previous treatments or have no other treatment options can join this study. They must be over 18, able to consent, and have a life expectancy of at least 3 months. Participants should not have active brain metastases or severe allergies to trial drugs.Check my eligibility
What is being tested?
The trial is testing the highest tolerable dose of BI 770371 alone or combined with ezabenlimab in adults with advanced cancer. Both are antibodies that may boost the immune system's ability to fight cancer. Treatments are given as infusions every three weeks for up to two years if beneficial.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (immune-related adverse events), infusion reactions, fatigue, and potentially others not listed here due to these being new treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have an advanced cancer that cannot be removed by surgery.
Select...
I have tried all known treatments for my condition without success.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in combination therapy
Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in monotherapy
Secondary outcome measures
Occurrence of Adverse Events (AEs) during the on-treatment period in combination therapy
Occurrence of Adverse Events (AEs) during the on-treatment period in monotherapy
Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in combination therapy
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Monotherapy dose escalationExperimental Treatment1 Intervention
Group II: Combination therapy dose escalationExperimental Treatment2 Interventions
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,532 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I have tried all known treatments for my condition without success.My side effects from previous cancer treatments are mild or gone, except for hair loss, nerve issues, thyroid problems, or menstrual changes.I need to keep taking certain medications that may affect the trial's safety.I've had severe allergic reactions to other antibody treatments.I haven't had any active cancer other than basal-cell skin cancer, cervical in situ carcinoma, or local tumors treated over 5 years ago.I haven't had chest radiotherapy in the last 4 weeks, but may have had other palliative radiotherapy.My brain metastases are stable, treated, and not worsening.I am over 18 and legally able to consent.I haven't had, nor plan to have, any major surgeries like a hip replacement around the trial period.I have an advanced cancer that cannot be removed by surgery.I have had lung inflammation or interstitial lung disease in the past 5 years.I have signed the consent form for this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Monotherapy dose escalation
- Group 2: Combination therapy dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings in this clinical investigation?
"According to information found on clinicaltrials.gov, this medical study is actively searching for volunteers and has been since May 9th 2022. The data was last edited November 14th of the same year."
Answered by AI
What safety parameters have been observed with BI 770371 usage?
"Considering the current state of clinical data for BI 770371, which is in its initial phase trial stage, our team has assigned it a safety rating of 1 on a scale from 1 to 3."
Answered by AI
How many participants are involved in this clinical study?
"This research necessitates 42 individuals that meet the criteria for inclusion. Those wishing to partake in this investigation have multiple options, such as Florida Cancer Specialists located in Sarasota or Hackensack University Medical Center situated in New jersey."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger