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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
No Placebo-Only Group

Summary

This trial is for adults with advanced colorectal or pancreatic cancer. It tests a new drug, BI 905711, combined with standard treatments to find the safest dose and see if it helps shrink tumors. Patients receive the treatment regularly and are monitored for health changes and tumor size.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1b: Confirmed objective response (OR) as assessed by the investigator
Phase 1b: Number of patients with DLTs during the MTD evaluation period assessed in the first 6 patients
Secondary study objectives
Phase 1b: Disease control, defined as complete response (CR), partial response (PR), or stable disease (SD) lasting at least 16 weeks according to RECIST 1.1
Phase 1b: Duration of objective response (OR)
Phase 1b: Progression Free Survival (PFS)
+1 more

Side effects data

From 2019 Phase 3 trial • 660 Patients • NCT01627249
18%
Vitreous floaters
17%
Vision blurred
13%
Conjunctival haemorrhage
12%
Eye pain
12%
Nasopharyngitis
11%
Hypertension
8%
Visual acuity reduced
7%
Headache
7%
Lacrimation increased
6%
Eye irritation
6%
Vitreous haemorrhage
6%
Dry eye
6%
Cataract
5%
Sinusitis
5%
Eye pruritus
2%
Renal failure chronic
2%
Renal failure
2%
Vomiting
1%
Osteomyelitis
1%
myocardial infarction
1%
coronary artery disease
1%
hypertensive heart disease
1%
Diabetic gastroparesis
1%
Cough
1%
Pneumonia
1%
Cellulitis
1%
Peripheral vascular disorder
1%
Diabetic ketoacidosis
1%
Dyspnoea
1%
Hypoglycaemia
1%
anaemia
1%
Chest pain
1%
Localised infection
1%
Sepsis
1%
Urinary tract infection
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aflibercept
Bevacizumab
Ranibizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~5540

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,548 Previous Clinical Trials
14,401,288 Total Patients Enrolled

Media Library

BI 905711 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05087992 — Phase 1
~3 spots leftby Nov 2025
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