Your session is about to expire
← Back to Search
Small Molecule Inhibitor
BI 1810631 for Advanced Cancer
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 non-haematologic malignancy. Patient must show presence of at least one measurable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Eastern Cooperative Oncology Group score of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of the trial treatment until end of month 12, up to 12 months.
Awards & highlights
Study Summary
This trial is testing a new drug, BI 1810631, to see if it can help people with advanced cancer who have not responded to other treatments. The first part of the study will test different doses of the drug to see what the highest dose the participants can tolerate is. The second part will test whether the drug can make tumours shrink.
Who is the study for?
Adults with advanced cancers showing changes in the HER2 gene, who have not responded to previous treatments, can join this trial. They must be generally healthy, able to take tablets daily or twice a day, and willing to use effective birth control. People with certain blood counts and organ functions are eligible. Those with brain metastases that don't need immediate treatment may also qualify.Check my eligibility
What is being tested?
The trial is testing BI 1810631's tolerable doses on various advanced cancers (Part 1) and its effectiveness in shrinking tumors in non-small cell lung cancer patients with specific HER2 mutations (Part 2). Participants will receive BI 1810631 orally as part of their ongoing treatment regimen while being monitored for health and tumor response.See study design
What are the potential side effects?
Since BI 1810631 is new and given for the first time to people in this study, potential side effects are closely monitored but could include typical reactions related to cancer medications such as nausea, fatigue, allergic reactions or other unforeseen issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, can't be surgically removed, and has at least one measurable tumor.
Select...
I am fully active or can carry out light work.
Select...
I am willing and able to follow the study's requirements for tumor biopsies, excluding those from the brain.
Select...
My organs are functioning well.
Select...
I am at least 18 years old or the legal age in my country.
Select...
I am using or willing to use effective birth control.
Select...
I have tried all known treatments for my condition without success, or I cannot undergo these treatments.
Select...
My lung cancer is non-squamous NSCLC with a HER2 mutation.
Select...
My non-squamous NSCLC has a HER2 mutation in the TKD.
Select...
I have not received any treatment for my non-squamous NSCLC.
Select...
My NSCLC has a HER2 mutation outside the TKD or is squamous with a TKD mutation.
Select...
My NSCLC has a HER2 mutation according to tests.
Select...
My non-squamous NSCLC has a HER2 mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of the trial treatment until end of month 12, up to 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of the trial treatment until end of month 12, up to 12 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase Ia: Maximum Tolerated Dose (MTD)
Phase Ia: Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period
Phase Ib - Cohort 3: Objective response according to RECIST 1.1 by investigator assessment
+2 moreSecondary outcome measures
Phase Ia: Area under the concentration-time curve of BI 1810631 in plasma (AUC0-t2)
Phase Ia: Maximum measured concentration of BI 1810631 in plasma (Cmax)
Therapeutic procedure
+21 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Phase Ib - Dose expansion part: Cohort 5Experimental Treatment1 Intervention
Group II: Phase Ib - Dose expansion part: Cohort 4Experimental Treatment1 Intervention
Group III: Phase Ib - Dose expansion part: Cohort 3Experimental Treatment1 Intervention
Group IV: Phase Ib - Dose expansion part: Cohort 2Experimental Treatment1 Intervention
Group V: Phase Ib - Dose expansion part: Cohort 1Experimental Treatment1 Intervention
Group VI: Phase Ia - Dose escalation partExperimental Treatment1 Intervention
Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 1810631
2023
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,536 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My ductal carcinoma in situ has been treated successfully.I have signed and understand the consent form for this trial.I had another cancer that was treated and is now considered cured.I need to keep taking certain medications that may affect the trial.I am not taking strong CYP3A4 inhibitors.My cancer is advanced, can't be surgically removed, and has at least one measurable tumor.I am willing to provide a sample of my tumor to check for HER2 status.My liver function tests are within the required limits.My cancer has a specific change in the HER2 gene or related genes.I have tried all known treatments for my condition without success, or I cannot undergo these treatments.My lung cancer is non-squamous NSCLC with a HER2 mutation.I have non-squamous NSCLC and have received at least one systemic therapy for advanced cancer.My NSCLC has a HER2 mutation outside the TKD or is squamous with a TKD mutation.My NSCLC has a HER2 mutation according to tests.I have advanced NSCLC and may or may not have received previous treatments.I've had platinum-based chemo and HER2 therapy for advanced cancer but it's gotten worse.I am fully active or can carry out light work.I have recovered from previous treatment side effects, except for hair loss, stable nerve damage, or controlled thyroid issues.I have NSCLC with specific genetic changes and have received at least one systemic treatment.My non-squamous NSCLC has a HER2 mutation in the TKD.I have brain metastases and cannot undergo immediate treatment for it.I haven't taken any cancer drugs or experimental drugs in the last 21 days or 5 half-lives, whichever is shorter.I am not taking medications like digoxin or dabigatran that are sensitive to certain proteins.I have been successfully treated for early-stage cervical cancer.My organs are functioning well.I am using or willing to use effective birth control.I haven't had major surgery in the last 4 weeks and don't plan any in the next 6 months.I am not taking medication that strongly affects liver enzymes.I am willing and able to follow the study's requirements for tumor biopsies, excluding those from the brain.My non-squamous NSCLC has a HER2 mutation.My skin cancer, not melanoma, has been treated successfully.I have not received any treatment for my non-squamous NSCLC.I have not had cancer other than the one being treated in this trial in the last 2 years.I am at least 18 years old or the legal age in my country.
Research Study Groups:
This trial has the following groups:- Group 1: Phase Ia - Dose escalation part
- Group 2: Phase Ib - Dose expansion part: Cohort 1
- Group 3: Phase Ib - Dose expansion part: Cohort 2
- Group 4: Phase Ib - Dose expansion part: Cohort 4
- Group 5: Phase Ib - Dose expansion part: Cohort 5
- Group 6: Phase Ib - Dose expansion part: Cohort 3
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.
Is this research endeavor available to participants at the present time?
"Affirmative, clinicaltrials.gov has recorded that this medical exploration is recruiting participants. It was posted on June 22nd 2021 and last edited November 2nd 2022 with a requirement of 266 patients across 3 sites."
Answered by AI
Do the risks of BI 1810631 outweigh its potential benefits for patients?
"Due to the experimental nature of BI 1810631, our team assigned it a rating of 1 on the safety scale. This is consistent with its current status as a Phase 1 trial, which indicates limited data regarding efficacy and security."
Answered by AI
How many participants is the research team accommodating in this experiment?
"Affirmative, clinicaltrials.gov documents that recruitment for this medical study is ongoing. Originally posted on June 22nd 2021 and most recently updated on November 2nd 2022, the trial requires 266 individuals across 3 separate sites to participate."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger