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Chemotherapy

Aplitibart for Metastatic Colorectal Cancer

Verified Trial
Phase 1
Recruiting
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you received just one prior systemic therapy (e.g., Chemotherapy, Hormone Therapies, Immunotherapies) to treat your metastatic colorectal cancer?
Was your last treatment for metastatic colorectal cancer longer than one month ago? Note that your answer to this question will not disqualify you from participating in this study
Must not have
Have you ever received Irinotecan, (otherwise known as Camptosar and/or Onivyde) to treat your colorectal cancer?
Timeline
Screening 4 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial will test if aplitibart in combination with FOLFIRI chemotherapy and bevacizumab is safe and effective in treating colorectal cancer that has relapsed or spread.

Who is the study for?
This trial is for adults with colorectal cancer that has returned or spread after treatment. Participants can have had prior treatments, must be able to perform light daily activities, and should not have been treated with irinotecan for their cancer.Check my eligibility
What is being tested?
The study is examining the safety and effectiveness of aplitibart combined with FOLFIRI chemotherapy and bevacizumab in treating advanced colorectal cancer. It aims to find out if this new combination can help patients whose cancer has relapsed or spread.See study design
What are the potential side effects?
Possible side effects include reactions related to aplitibart, such as infusion-related symptoms, fatigue, nausea from FOLFIRI chemotherapy, and increased risk of bleeding or hypertension due to bevacizumab.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 4 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 4 weeks for screening, Varies for treatment, and 36 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
To continue to assess the safety of aplitibart in combination with chemotherapy.
To understand how long aplitibart, in combination with chemotherapy, keeps your tumor from growing.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ph1b: Bevacizumab + FOLFIRIExperimental Treatment2 Interventions
Bevacizumab will be administered intravenously in combination FOLFIRI.
Group II: Ph1b: Aplitibart + FOLFIRI + BevacizumabExperimental Treatment3 Interventions
Aplitibart will be administered intravenously in combination with FOLFIRI and Bevacizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
FOLFIRI
2005
Completed Phase 3
~5860

Find a Location

Media Library

Azacitidine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04553692 — Phase 1
Colorectal Cancer Research Study Groups: Ph1b: Bevacizumab + FOLFIRI, Ph1b: Aplitibart + FOLFIRI + Bevacizumab
Colorectal Cancer Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT04553692 — Phase 1
Azacitidine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04553692 — Phase 1

Frequently Asked Questions

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

Can I participate in this clinical trial while receiving other treatments?

"No, if you participate in this trial you may not receive any other treatment for your cancer as long as you are on the trial."

Verified Answer

Can I leave this clinical trial if I change my mind or experience side effects?

"Yes you can leave a clinical trial at any time."

Verified Answer

How long will I be required to participate in this clinical trial?

"There is no time requirement. You will be asked to continue to participate in this trial until your cancer worsens"

Verified Answer

What if I require support for travel and accommodation to participate in the study?

"You will be reimbursed for your travel costs if you decide to participate in the study. You will also be provided support through a concierge service if you need assistance scheduling appointments."

Verified Answer

How many people have been treated with aplitibart before me?

"More than 50 people have been treated with aplitibart."

Verified Answer

Will I know what medication I'm taking?

"Your study doctor or study staff will tell you which treatment group you will be in and you will receive aplitibart in combination with the standard of care FOLFIRI with bevacizumab (or an approved biosimilar drug) OR you will receive standard of care FOLFIRI with bevacizumab (or an approved biosimilar drug)."

Verified Answer

If I receive the standard of care arm without aplitibart, will I have the chance to ever receive aplitibart?

"Yes you will. If your disease worsens under standard of care, you will have a chance to receive aplitibart in combination with standard of care."

Verified Answer
Recent research and studies
clinicaltrials.govStudy
Phase 1a/1b Study of aplitibart Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers
2020. "Phase 1a/1b Study of aplitibart Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04553692.
All > Colorectal Cancer San Diego > Chondrosarcoma
~177 spots leftby Nov 2026
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