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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 504 hours
Awards & highlights
Study Summary
This trial is testing a drug to see if it is safe and effective for treating advanced solid malignancies. The trial will evaluate the drug's safety by monitoring for side effects, as well as its efficacy by measuring how well it shrinks tumors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 504 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 504 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1a: Number of patients experiencing Dose Limiting Toxicity (DLT) graded according to CTCAE Version 4.03 / 5.0, observed in the first cycle (3 weeks) in order to meet the objective of assessment of the Maximum-tolerated Dose of BI 754091.
Phase 1b: Confirmed Objective Response (OR), defined as the best overall response of confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Investigator.
Phase 1b: Number of patients with Dose Limiting Toxicity (DLT) observed during the entire treatment period.
Secondary outcome measures
Phase 1a: Area Under the Concentration-Time Curve (AUC0-504) of BI 754091 in plasma over the time interval from 0 to 504 hours (if feasible)
Phase 1a: Confirmed Objective Response (OR) according to RECIST v1.1 as assessed by the Investigator)
Phase 1a: Maximum Measured Concentration (Cmax) of BI 754091 in plasma (if feasible)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: BI 754091Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 754091
2018
Completed Phase 1
~520
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Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,180 Total Patients Enrolled
3 Trials studying Tumors
1,624 Patients Enrolled for Tumors
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a lung infection called pneumonitis in the past 5 years.You have had serious allergic reactions to other types of medicines called monoclonal antibodies.
Research Study Groups:
This trial has the following groups:- Group 1: BI 754091
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.
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