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BI 905711 for Gastrointestinal Cancer

Hospital Clínico de Valencia, Valencia, Spain

Targeting 3 different conditionsBI 905711Phase 1Waitlist AvailableResearch Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase Ia (dose escalation only): Histologically or cytologically confirmed, advanced unresectable or metastatic gastrointestinal cancers of following histologies: Colorectal adenocarcinoma, Gastric adenocarcinoma, Esophageal adenocarcinoma, Pancreatic adenocarcinoma, Cholangiocarcinoma and gallbladder carcinoma, Small intestine adenocarcinoma

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to day 1 and up to day 19

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is exploring the safety and efficacy of BI 905711 in order to determine a recommended dose for further study.

Eligible Conditions

Gastrointestinal Tumors
Pancreatic Cancer
Bile Duct Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 1 and up to day 19

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 1 and up to day 19

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 1 and up to day 19 for reporting.

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) defined as the highest dose with less than 25% risk of the true DLT rate being equal or above 33% during the MTD evaluation period

Phase Ia - Number of patients with DLTs in the MTD evaluation period

Phase Ib - Objective response based on RECIST 1.1 criteria

+1 more

Secondary outcome measures

Phase Ia - AUC0-t2: area under the concentration-time curve of BI 905711 in plasma

Phase Ia - Cmax: maximum measured concentration of BI 905711 in plasma

Phase Ia - Objective response based on RECIST 1.1 criteria in patients with measurable disease

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Phase Ib: BI 905711 - dose level 4Experimental Treatment1 Intervention

Group II: Phase Ib: BI 905711 - dose level 3Experimental Treatment1 Intervention

Group III: Phase Ib: BI 905711 - dose level 2Experimental Treatment1 Intervention

Group IV: Phase Ib: BI 905711 - dose level 1Experimental Treatment1 Intervention

Group V: Phase Ia: BI 905711 - dose escalationExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,469 Previous Clinical Trials

10,417,116 Total Patients Enrolled

Media Library

BI 905711 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04137289 — Phase 1

Gastrointestinal Tumors Research Study Groups: Phase Ia: BI 905711 - dose escalation, Phase Ib: BI 905711 - dose level 2, Phase Ib: BI 905711 - dose level 1, Phase Ib: BI 905711 - dose level 3, Phase Ib: BI 905711 - dose level 4

Gastrointestinal Tumors Clinical Trial 2023: BI 905711 Highlights & Side Effects. Trial Name: NCT04137289 — Phase 1

BI 905711 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04137289 — Phase 1

Frequently Asked Questions

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

Are there any opportunities to join the study at this time?

"Affirmative. Clinicaltrials.gov verifies that the trial is currently recruiting, having initially been posted on March 11th 2020 and last modified November 28th 2022. The research requires 140 volunteers at a total of 4 sites."

Answered by AI

To what extent is this medical study involving participants?

"This experiment necessitates the recruitment of 140 suitable patients, and is overseen by Boehringer Ingelheim. Clinical trials will take place in Yale Cancer Center, New Haven Connecticut e Cancer Center, New Haven Connecticut and START South Texas Accelerated Research Therapeutics LLC based out of San Antonio, Texas."

Answered by AI

Are there any potential risks associated with BI 905711 for patients?

"Due to its Phase 1 status, BI 905711's safety assessment is rated at a 1 as there is only minimal data available that confirms its efficacy and security."

Answered by AI

What is the current count of medical sites participating in this trial?

"Patients may participate in the clinical trial at Yale Cancer Center in New Haven, START South Texas Accelerated Research Therapeutics LLC in San Antonio, The University of Texas MD Anderson Cancer Center in Houston, and 4 other medical sites."

Answered by AI

Recent research and studies

Molecular Cancer TherapeuticsJournal

Selective Tumor Cell Apoptosis and Tumor Regression in Cdh17-positive Colorectal Cancer Models Using BI 905711, a Novel Liver-sparing TRAILR2 Agonist

García-Martínez, Juan Manuel, Shirley Wang, Cordula Weishaeupl, Andreas Wernitznig, Paolo Chetta, Catarina Pinto, Jason Ho, et al.. 2021. “Selective Tumor Cell Apoptosis and Tumor Regression in Cdh17-positive Colorectal Cancer Models Using BI 905711, a Novel Liver-sparing TRAILR2 Agonist”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-20-0253.

clinicaltrials.govStudy

A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer

2020. "A Study to Find a Safe and Effective Dose of BI 905711 in Patients With Advanced Gastrointestinal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04137289.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer