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BI 1701963 + Trametinib for Advanced 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
Patients must have received both chemotherapy and immunotherapy
Signed and dated written informed consent in accordance with GCP and local legislation prior to admission to the trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can shrink tumors in adults with advanced cancer that didn't respond to previous chemotherapy.

Who is the study for?
Adults with advanced cancer (solid tumors) and a specific KRAS mutation, who have seen their disease progress despite standard treatments. They must be over 18, not pregnant if female of childbearing potential, and have at least one measurable tumor lesion. Participants should be in good physical condition (ECOG status 0 or 1) and have adequate organ function.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of two drugs: BI 1701963 alone, which is new to humans, and combined with trametinib, an approved MEK inhibitor. The goal is to determine the highest tolerable doses that can shrink tumors in participants who will take these daily as tablets.See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer medications such as nausea, fatigue, skin rash or itching. Since BI 1701963 is new for human use its full range of side effects isn't known yet but could be similar to other drugs targeting KRAS mutations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received both chemotherapy and immunotherapy.
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I have signed and understand the consent form for this trial.
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I am a woman who can have children and have a negative pregnancy test.
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My organs are working well.
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This applies to all parts of the screening process.
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My cancer has worsened despite treatment, or there are no standard treatments for my cancer type and stage.
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My cancer has a KRAS mutation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My lung cancer is mainly adenocarcinoma.
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My lung cancer is at an advanced stage (IIIb or IV).
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 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) - Number of patients with DLTs during the on-treatment period
Dose confirmation (Part B) and expansion (Part C) - Objective response
Dose escalation (Part A) - Maximum tolerated dose (MTD) based on number of dose-limiting toxicities (DLTs)
Secondary outcome measures
Dose confirmation (Part B) - Number of patients with Grade ≥3 treatment-related adverse events observed during the on-treatment period
Dose confirmation (Part B) - Pharmacokinetic parameters of BI 1701963: AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
Dose confirmation (Part B) - Pharmacokinetic parameters of BI 1701963: Cmax (maximum measured concentration of the analyte in plasma)
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: BI 1701963 monotherapyExperimental Treatment1 Intervention
Group II: BI 1701963 + TrametinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550
BI 1701963
2021
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,502 Previous Clinical Trials
11,339,875 Total Patients Enrolled

Media Library

BI 1701963 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04111458 — Phase 1
Solid Tumors Research Study Groups: BI 1701963 + Trametinib, BI 1701963 monotherapy
Solid Tumors Clinical Trial 2023: BI 1701963 Highlights & Side Effects. Trial Name: NCT04111458 — Phase 1
BI 1701963 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04111458 — Phase 1

Frequently Asked Questions

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

Has research been conducted on BI 1701963 previously?

"BI 1701963 was first tested at the University of Chicago Medical Center in 2012, and since then there have been 69 trials that were concluded. Nowadays, 92 separate studies are taking place, many of which being conducted out of Houston Texas."

Answered by AI

Are there vacancies available for persons interested in participating in this research study?

"This trial has ended its recruitment of patients. It was initially announced on October 28th 2019 and updated lastly on November 14th 2022. For other studies, there are presently 2380 trials recruiting participants with solid tumors and kras mutation; sos1 as well as 92 studies seeking enrolment for BI 1701963."

Answered by AI

How many locations are participating in this experiment?

"Currently, The University of Texas MD Anderson Cancer Centre in Houston, Sarah Cannon Research Institute in Nashville, and Dana-Farber Cancer Institute in Boston are among the 4 clinical trial sites actively recruiting patients for this study."

Answered by AI

How many participants are taking part in this experiment?

"This study has closed its recruitment period; the initial posting was on October 28th 2019 and it last updated November 14th 2022. If you are in search of other trials, there exist 2380 medical studies actively recruiting patients with solid tumors carrying KRAS mutation SOS1 mutations, as well as 92 clinical trials for BI 1701963 also seeking participants."

Answered by AI

Has the FDA acquiesced to BI 1701963's clinical use?

"Since BI 1701963 is still in its early stages of testing, the safety and efficacy profile has been given a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)
2019. "A Study to Test Different Doses of BI 1701963 Alone and Combined With Trametinib in Patients With Different Types of Advanced Cancer (Solid Tumours With KRAS Mutation)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04111458.
~13 spots leftby Apr 2025
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