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Monoclonal Antibodies
BI 1831169 + Ezabenlimab for Advanced Cancers
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
Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumor
If only one accessible lesion is available, this lesion must have a minimum lesion diameter of ≥10mm for injection of BI 1831169 and be amenable to biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 49 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it's effective and safe.
Who is the study for?
Adults with advanced solid tumors that haven't responded to previous treatments or have no other options can join. They need at least one tumor suitable for injection and biopsy, be over 18 years old, in good health for trial procedures, have a performance status of 0 or 1, and proper organ function. Patients must not have had recent radiation to the target lesions or suffer from conditions like uncontrolled HIV/AIDS.Check my eligibility
What is being tested?
The study is testing BI 1831169 alone and combined with ezabenlimab on different types of advanced cancers. Part one determines the highest tolerable dose of BI 1831169; part two does the same for its combination with ezabenlimab. Treatments are given every three weeks via injection into the tumor or infusion into a vein.See study design
What are the potential side effects?
Potential side effects include typical immune-related reactions such as inflammation in various organs due to an activated immune system fighting cancer cells, possible allergic responses to treatment components, fatigue from body's response to therapy, and infection risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.
Select...
I have a tumor that is at least 10mm wide and can be biopsied.
Select...
I have two tumors that can be biopsied; one is at least 10mm wide.
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I am fully active or have some restrictions but can still care for myself.
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My liver function tests are within the required limits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 49 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 49 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 (Monotherapy), Dose escalation: Number of patients experiencing Dose limiting toxicities (DLTs) during the Maximum tolerated dose (MTD) evaluation period.
Part 1 (Monotherapy), Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed partial response (itPR)
Part 2 (Combination Therapy), Dose escalation: Number of patients experiencing Dose limiting toxicities (DLTs) during the Maximum tolerated dose (MTD) evaluation period.
Secondary outcome measures
Part 1 (Monotherapy), Dose escalation: Number of patients experiencing DLTs during all treatment cycles.
Part 1 (Monotherapy), Dose escalation: Number of patients with adverse events during the on-treatment period.
Part 1 (Monotherapy), Dose expansion: Number of patients with adverse events during the on-treatment period.
+2 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Part 2 (Combination therapy): Arm FExperimental Treatment2 Interventions
Arm F: i.t.+i.v. administration
Group II: Part 2 (Combination therapy): Arm EExperimental Treatment2 Interventions
Arm E: Intravenous (i.v.) administration
Group III: Part 2 (Combination therapy): Arm DExperimental Treatment2 Interventions
Arm D: Intratumoral (i.t.) administration
Group IV: Part 1 (Monotherapy): Arm CExperimental Treatment1 Intervention
Arm C: i.t.+i.v. administration
Group V: Part 1 (Monotherapy): Arm BExperimental Treatment1 Intervention
Arm B: Intravenous (i.v.) administration
Group VI: Part 1 (Monotherapy): Arm AExperimental Treatment1 Intervention
Arm A: Intratumoral (i.t.) administration
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,790 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active infection needing treatment when the trial starts.I have tumors that can be easily reached for treatment or biopsy.I have not had radiotherapy in the last 4 weeks, except for short-term pain relief or to prevent bone fractures.I am not on antiretroviral therapy.I have brain tumors or cancer spread to the brain, confirmed by recent scans.You have had an allergic reaction or are highly sensitive to any of the ingredients in the study drug.I have tried all known treatments for my cancer or cannot use them, and they haven't worked.I haven't had radiation on any area to be injected or biopsied in the last 6 months.I have a tumor that is at least 10mm wide and can be biopsied.I started HIV treatment less than 4 weeks ago.I have at least one tumor that can be easily reached for treatment and biopsy.I have two tumors that can be biopsied; one is at least 10mm wide.All my previous cancer treatment side effects are mild, except for hair loss, dry mouth, or stable hormone issues.I have HIV and meet specific health criteria.I am 18 years old or older, or at the legal age of consent for my country.My cancer is advanced, cannot be surgically removed, and has either spread or not responded to treatment.I have a tumor that can be easily biopsied or I am willing to undergo procedures for biopsy.I have not had any major surgery in the last 4 weeks.I haven't had AIDS-related infections in the last year and am under HIV specialist care.I am fully active or have some restrictions but can still care for myself.My recent tests show my organs and bone marrow are working well.My blood tests show enough neutrophils and platelets without needing growth factors recently.My liver function tests are within the required limits.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1 (Monotherapy): Arm A
- Group 2: Part 1 (Monotherapy): Arm C
- Group 3: Part 2 (Combination therapy): Arm E
- Group 4: Part 1 (Monotherapy): Arm B
- Group 5: Part 2 (Combination therapy): Arm D
- Group 6: Part 2 (Combination therapy): Arm F
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.
What is the enrollment capacity of this research project?
"To satisfy the requirements of this study, 117 participants who meet its inclusion criteria are required. The sponsor for this research is Boehringer Ingelheim and it will be conducted from John Wayne Cancer Institute in Santa Monica, California and University of Iowa Hospitals and Clinics in Iowa City, Iowa."
Answered by AI
Is enrollment still open for this experimental trial?
"Affirmative. According to the information displayed on clinicaltrials.gov, this medical trial has been actively recruiting since March 11th 2022 and 117 participants are needed from 3 distinct locations."
Answered by AI
Has BI 1831169 received regulatory authorization from the FDA?
"BI 1831169 is believed to be moderately safe, given its Phase 1 status. Limited data exists that demonstrates the drug's efficacy and safety profiles."
Answered by AI
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