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Monoclonal Antibodies

Botensilimab + Balstilimab + Regorafenib for Colorectal Cancer

Phase 2

Waitlist Available

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

Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test with agreement to use effective birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy

Age: ≥ 18 years

Must not have

Clinically significant cardiovascular disease

Uncontrolled infection with human Immunodeficiency virus (HIV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days after completion of study treatment

Awards & highlights

Summary

"This trial is testing if a combination of three drugs, botensilimab, balstilimab, and regorafenib, works better than just botensilimab and bal

Who is the study for?

This trial is for patients with advanced or metastatic microsatellite stable colorectal cancer. It's suitable for those who have cancer that has spread from the original site to other body parts. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

What is being tested?

The study compares two treatment sets: one combines botensilimab, balstilimab, and regorafenib; the other uses just botensilimab and balstilimab. These drugs aim to boost the immune system's fight against cancer and block proteins that help tumor cells grow.

What are the potential side effects?

Potential side effects may include typical reactions to immunotherapy such as fatigue, skin reactions, digestive issues, and possible organ inflammation. Regorafenib might cause hand-foot skin reactions, hypertension, fatigue, diarrhea among others.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman who can have children, not pregnant, and agree to use birth control or abstain from sex during the study and for 120 days after.

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I am 18 years old or older.

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I am fully active and can carry on all pre-disease activities without restriction.

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My colon or rectum cancer is advanced, spreading, and not responsive to DNA mismatch repair.

Exclusion Criteria

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

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I have a serious heart condition.

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I do not have an uncontrolled HIV infection.

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I have previously received immunotherapy.

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I have previously been treated with regorafenib.

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I haven't had major surgery in the last 4 weeks.

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I rely on IV for nutrition or hydration.

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I do not have any uncontrolled serious illnesses.

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My high blood pressure is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of dose limiting toxicities (Safety lead in)

Response rate (Phase II) Immune-Modified RECIST

Response rate (Phase II) RECIST

+1 more

Secondary study objectives

Duration of treatment response

Incidence of adverse events

Overall survival

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BBR (botensilimab, balstilimab, regorafenib)Experimental Treatment7 Interventions

Patients receive botensilimab IV over 60 minutes on day 1 of each cycle, balstilimab IV over 30 minutes on days 1, 15, and 29 of each cycle, and regorafenib PO QD on days 1-7, 15-21, and 29-35 of each cycle or on days 1-5, 15-19, and 29-33 of each cycle. Cycles repeat every 42 days for up to 2 cycles of botensilimab and up to 2 years of balstilimab and regorafenib in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the trial. Patients also undergo tumor biopsy during screening and on study.

Group II: Arm BB (botensilimab, balstilimab)Experimental Treatment6 Interventions

Patients receive botensilimab IV over 60 minutes on day 1 of each cycle and balstilimab IV over 30 minutes on days 1, 15, and 29 of each cycle. Cycles repeat every 42 days for up to 2 cycles of botensilimab and up to 2 years of balstilimab in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and blood sample collection throughout the trial. Patients also undergo tumor biopsy during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Biospecimen Collection

2004

Completed Phase 3

~2020

Biopsy

2014

Completed Phase 4

~1090

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Regorafenib

2014

Completed Phase 2

~1600

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,916 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

596 Previous Clinical Trials

1,923,453 Total Patients Enrolled

Marwan G FakihPrincipal InvestigatorCity of Hope Medical Center

4 Previous Clinical Trials

214 Total Patients Enrolled

~56 spots leftby Jan 2027

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