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Monoclonal Antibodies

Futuximab/modotuximab for Colorectal Cancer (COLSTAR Trial)

Phase 3
Waitlist Available
Led By Fortunato Ciardiello
Research Sponsored by Institut de Recherches Internationales Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with measurable or non-measurable lesion
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years 9 months
Awards & highlights

COLSTAR Trial Summary

This trial is testing a new combo drug for people with metastatic colorectal cancer who have already tried other treatments. The first part is to see if it's safe, and the second part is to see if it's better than the current best treatment.

Eligible Conditions
  • Metastatic Colorectal Cancer

COLSTAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have visible signs of a medical condition that can be measured or not measured by medical tests.

COLSTAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years 9 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
Incidence of Dose-limiting Toxicities (DLTs) (Safety Lead-In Part)
Overall Survival (OS) (In Double Negative, KRAS/NRAS and BRAF Wild Type Patients) (Phase III Part)
Secondary outcome measures
Adverse Events (Phase III Part)
Overall Survival (In Triple Negative) (Phase III Part)
Overall Survival (Safety Lead-In Part)
+1 more

COLSTAR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Futuximab/modotuximab combined with trifluridine/tipiracil (Safety Lead-In and Phase III parts)Experimental Treatment2 Interventions
Group II: Trifluridine/tipiracil (Phase III part)Active Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trifluridine/Tipiracil
2019
Completed Phase 3
~790

Find a Location

Who is running the clinical trial?

ADIR, a Servier Group companyIndustry Sponsor
32 Previous Clinical Trials
4,389 Total Patients Enrolled
Institut de Recherches Internationales ServierLead Sponsor
86 Previous Clinical Trials
69,554 Total Patients Enrolled
Fortunato CiardielloPrincipal InvestigatorUniversity of Campania "Luigi Vanvitelli"
3 Previous Clinical Trials
460 Total Patients Enrolled

Media Library

Futuximab/modotuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05223673 — Phase 3
Colorectal Cancer Research Study Groups: Trifluridine/tipiracil (Phase III part), Futuximab/modotuximab combined with trifluridine/tipiracil (Safety Lead-In and Phase III parts)
Colorectal Cancer Clinical Trial 2023: Futuximab/modotuximab Highlights & Side Effects. Trial Name: NCT05223673 — Phase 3
Futuximab/modotuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05223673 — Phase 3

Frequently Asked Questions

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

How many individuals are receiving therapy through this clinical trial?

"That is correct. The clinicaltrials.gov website lists this trial as active and presently looking for 500 patients from 2 locations. The first posting was on 4/21/2022 with the most recent update being on 7/5/2022."

Answered by AI

Is Futuximab/modotuximab a safe medication for people?

"Futuximab/modotuximab is a Phase 3 trial drug, so it has some evidence of efficacy and multiple rounds of data supporting safety. We rated its safety as a 3."

Answered by AI
~2 spots leftby Mar 2025