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BI 905711 + Chemotherapy for Gastrointestinal 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 13 months.
Awards & highlights

Study Summary

This trial is for adults with advanced colorectal or pancreatic cancer. The first part is to find the highest tolerable dose of BI 905711, and the second part is to see if BI 905711 makes tumours shrink. BI 905711 is given every 2 weeks as an infusion, and participants can stay in the study for as long as the treatment is effective and tolerable.

Eligible Conditions
  • Metastatic Gastrointestinal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 13 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 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
Phase 1a: Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being equal or above 33% during the MTD evaluation period
Phase 1a: Number of patients with DLTs in the MTD evaluation period
Phase 1b: Confirmed objective response (OR) as assessed by the investigator
+1 more
Secondary outcome measures
Phase 1a: AUC0-t2: Area under the concentration time-curve in plasma of BI 905711 after multiple cycles
Phase 1a: AUC0-t2: Area under the concentration-time curve in plasma of BI 905711 during the first cycle
Phase 1a: Cmax: Maximum measured plasma concentration of BI 905711 after multiple cycles
+9 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 1b: FOLFIRI + BevacizumabExperimental Treatment2 Interventions
Phase 1b: Dose Expansion: Randomized cohort in 2nd line colorectal adenocarcinoma (CRC); Arm B.
Group II: Phase 1b: BI 905711 + FOLFIRI + BevacizumabExperimental Treatment3 Interventions
Phase 1b: Dose Expansion: Randomized cohort in 2nd line colorectal adenocarcinoma (CRC); Arm A.
Group III: Phase 1b: BI 905711 + FOLFIRIExperimental Treatment2 Interventions
Phase 1b: Dose Expansion: Single arm cohort in 2nd line Pancreatic Ductal Adenocarcinoma (PDAC)
Group IV: Phase 1a: BI 905711 + FOLFIRI + BevacizumabExperimental Treatment3 Interventions
Phase 1a: Dose escalation in colorectal adenocarcinoma (CRC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 905711
2020
Completed Phase 1
~130
FOLFIRI
2005
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,515 Previous Clinical Trials
11,347,275 Total Patients Enrolled

Media Library

BI 905711 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05087992 — Phase 1
~4 spots leftby Jun 2025