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Monoclonal Antibodies

Triple Therapy for Colorectal Cancer

Phase 1 & 2
Led By Marwan G Fakih
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological or cytological confirmed advanced, metastatic, or progressive proficient mismatch repair (pMMR)/MSS adenocarcinoma of colon or rectum
Age: >= 18 years
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial tests a combo of immunotherapy & targeted drugs to treat colorectal cancer that has spread. It may help the body's immune system attack cancer & inhibit tumor growth.

Who is the study for?
This trial is for adults with advanced colorectal cancer that's spread and hasn't responded to previous chemotherapy. Participants must be in good physical condition, able to take oral medication, have a life expectancy of at least 3 months, and use effective birth control if applicable. They can't join if they've had certain recent health issues or treatments, are on high-dose steroids or other immune-suppressing drugs, or have autoimmune diseases.Check my eligibility
What is being tested?
The study tests a combination of botensilimab (an immunotherapy drug), balstilimab (another immunotherapy), and regorafenib (a drug that inhibits tumor growth) in patients with metastatic colorectal cancer. The goal is to see if this combo is more effective than the standard treatment alone.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells as well as typical chemotherapy effects like fatigue, digestive problems, skin reactions, liver issues, increased risk of infections and potential bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My colon or rectum cancer is advanced, spreading, and not responsive to certain DNA repair errors.
I am 18 years old or older.
I have 5 or fewer liver metastases.
I can swallow and digest pills.
I am fully active and can carry on all pre-disease activities without restriction.
My colorectal cancer is not MSI-High.
My cancer has worsened after treatment with specific chemotherapy drugs and targeted therapy.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 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 (DLT) (Phase I)
Overall response rate (ORR) (Phase II)
Recommended phase 2 dose of botensilimab, balstilimab, and regorafenib (Phase I)
Secondary outcome measures
Duration of response (Phase II)
Incidence of DLTs (Phase I)
Incidence of toxicity (Phase II)
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (botensilimab, balstilimab and regorafenib)Experimental Treatment5 Interventions
Patients receive botensilimab IV, balstilimab IV, and regorafenib PO on study. Patients also undergo CT and collection of blood throughout the study.
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
Completed Phase 2
Biospecimen Collection
Completed Phase 2
Completed Phase 2

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,397 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,062 Total Patients Enrolled
Marwan G FakihPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
151 Total Patients Enrolled

Media Library

Balstilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05672316 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Treatment (botensilimab, balstilimab and regorafenib)
Colorectal Cancer Clinical Trial 2023: Balstilimab Highlights & Side Effects. Trial Name: NCT05672316 — Phase 1 & 2
Balstilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05672316 — Phase 1 & 2

Frequently Asked Questions

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

Are there still opportunities for people to join this scientific experiment?

"Unfortunately, according to the clinicaltrials.gov page, this medical trial is not presently recruiting participants; it was first listed on March 9th 2023 and last updated on January 3rd 2023. Conversely, there are currently 3717 other trials accepting patients."

Answered by AI
~22 spots leftby Nov 2024