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BI 1823911 + BI 1701963 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function as follows: Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; hemoglobin ≥9.0 g/dL; platelets ≥100 x 10^9/L; Total bilirubin ≤1.5 times the upper limit of normal; Creatinine ≤1.5 x ULN; Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x ULN, for patients with liver metastases ≤5 x ULN; Age ≥18 years of age, or over the legal age of consent as required by local legislation
KRAS mutation status: Kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation in tumour tissue or blood based on previously performed local testing using a validated test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 39 months
Awards & highlights

Study Summary

This trial is for adults with advanced or metastatic cancer who haven't had success with other treatments or for whom no treatment exists. The study is testing two drugs, BI 1823911 and BI 1701963, to see if they can shrink tumors. The trial will determine the best dose of the drugs and how well they work alone and in combination.

Who is the study for?
Adults with advanced cancers (like lung, colorectal, pancreatic, bile duct) that have a specific KRAS mutation and haven't responded to previous treatments or lack treatment options. They must be relatively healthy (ECOG status of 0 or 1), have certain normal organ function levels, measurable tumors per RECIST criteria, and acceptable blood counts.Check my eligibility
What is being tested?
The trial is testing BI 1823911 alone and combined with BI 1701963 in different doses to find the highest tolerable amount for patients. It aims to see if these drugs can shrink tumors in those with a particular KRAS mutation. Participants will take tablets daily as long as they benefit without severe side effects.See study design
What are the potential side effects?
Specific side effects are not listed but generally may include typical reactions from cancer medications such as nausea, fatigue, liver issues, changes in blood counts leading to increased infection risk or bleeding problems. Regular health checks monitor any unwanted effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific KRAS G12C mutation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has worsened despite treatment, or there are no standard treatments for my cancer type and stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 39 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 39 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose confirmation (Part B) and expansion (Part C) - Monotherapy and combination therapy: Objective response (OR) defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR)
Dose escalation (Part A) - Monotherapy and combination therapy: Number of patients experiencing Dose limiting toxicities (DLTs) during the Maximum tolerated dose (MTD) evaluation period for BI 1823911 in monotherapy and in each combination
Secondary outcome measures
All study parts, BI 1701963: Area under the plasma concentration-time curve at steady state (AUCss)
All study parts, BI 1701963: Area under the plasma concentration-time curve from time zero to time t (AUCτ)
All study parts, BI 1701963: Maximum concentration (Cmax)
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Monotherapy ArmExperimental Treatment2 Interventions
Each arm consists of three parts (dose escalation (A), dose confirmation (B), and dose expansion (C).
Group II: Combination Therapy ArmExperimental Treatment2 Interventions
Will be started after confirmation of safety in the Monotherapy Arm. Each arm consists of three parts (dose escalation (A), dose confirmation (B), and dose expansion (C).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1701963
2021
Completed Phase 1
~10
Midazolam
2018
Completed Phase 4
~1910

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,508 Previous Clinical Trials
11,340,921 Total Patients Enrolled

Media Library

BI 1701963 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04973163 — Phase 1
Solid Tumors Research Study Groups: Monotherapy Arm, Combination Therapy Arm
Solid Tumors Clinical Trial 2023: BI 1701963 Highlights & Side Effects. Trial Name: NCT04973163 — Phase 1
BI 1701963 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04973163 — Phase 1
Solid Tumors Patient Testimony for trial: Trial Name: NCT04973163 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we the first to study BI 1823911 in this way?

"67 clinical trials are currently studying BI 1823911. 10 of those trials are in the final stage (phase 3), with the majority of the research being conducted in Porto Alegre, Brazil. Across the world, there are a total of 428 locations running BI 1823911 trials."

Answered by AI

What conditions does BI 1823911 commonly treat?

"BI 1823911 is a medication that is commonly used to treat anxiety. However, it can also be prescribed for other conditions such as epilepsy and amnesia."

Answered by AI

Are there any dangers to patients that have been linked with BI 1823911?

"BI 1823911 is still in Phase 1 of testing, meaning that there is limited data to support its safety and efficacy. Our team at Power rates its safety as a 1."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
What site did they apply to?
Mary Crowley Cancer Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Hi I feel like advancing science, and in the long run, providing a better understanding of the nature of the universe brings us all a tiny bit closer to God.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation
2021. "A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04973163.
~5 spots leftby Nov 2024
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