Study on Botensilimab, Balstilimab, and Regorafenib for Treating Advanced Colorectal Cancer After Chemotherapy

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05672316

Provider View

This clinical trial is testing a combination of three drugs—botensilimab, balstilimab, and regorafenib—to see if they can help treat colorectal cancer that has spread and did not respond to previous chemotherapy. The study aims to find out if this combination can better control the cancer compared to using these drugs separately.

Patient Parameters

Program Overview

This study is exploring a new treatment for colorectal cancer that has spread to other parts of the body and has not responded to previous chemotherapy. The treatment combines two immunotherapy drugs, botensilimab and balstilimab, which help the immune system attack cancer cells, with regorafenib, a drug that may stop tumors from growing by blocking blood vessel formation. The study will test if this combination is more effective than using the drugs alone.

Description

The study is divided into two phases. In Phase I, researchers will determine the best dose of the drug combination for future studies. In Phase II, they will evaluate how well the treatment works in shrinking tumors and improving survival rates in patients with advanced colorectal cancer.

Participants will receive botensilimab and balstilimab through an IV and take regorafenib orally. They will also undergo regular CT scans and blood tests to monitor their health and the treatment's effects.

The study will also look at the safety of the treatment and any side effects that may occur. Researchers will collect information on how the treatment affects the cancer's progression and the patients' overall survival. Additionally, they will study certain biomarkers in the blood to understand how the treatment works and why some patients may respond better than others.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced or metastatic colorectal cancer that is microsatellite stable (MSS) and has not responded to previous chemotherapy.
  • Be able to swallow and absorb oral tablets.
  • Have measurable cancer that can be tracked using standard criteria.
  • Have specific genetic markers related to the cancer.
  • Have tried and not responded to certain chemotherapy drugs, including fluoropyrimidines, irinotecan, oxaliplatin, and anti-EGFR therapy if applicable.
  • Have progressed on or after the last treatment within six months before joining the study.
  • Have no more than five liver metastases if the cancer has spread to the liver.
  • Have normal liver and kidney function as indicated by specific blood tests.
  • Have adequate blood cell counts, including white blood cells, hemoglobin, and platelets.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 120 days after the last dose.
  • Men and women must agree to use birth control or abstain from sexual activity during the study and for a specified period after the last dose.

Exclusion Criteria

  • Have previously received immunotherapy targeting PD-1, PD-L1, or CTLA-4.
  • Require systemic treatment with corticosteroids or other immunosuppressive medications.
  • Have had an organ transplant.
  • Have had major surgery within four weeks before starting the study.
  • Have a history of severe allergic reactions to any of the study drugs.
  • Have active autoimmune diseases requiring treatment within the past two years.
  • Have uncontrolled high blood pressure.
  • Have had recent serious heart problems or blood clots.
  • Have bowel obstruction symptoms related to cancer.
  • Have significant side effects from previous cancer treatments.
  • Have active bleeding or non-healing wounds.
  • Have active brain metastases unless treated and stable.
  • Have another active cancer requiring treatment.
  • Have lung disease or pneumonitis.
  • Have psychiatric or substance abuse issues that interfere with study participation.
  • Have had a recent COVID-19 infection.
  • Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Depend on intravenous nutrition or hydration.
  • Have any other condition that may interfere with study participation or safety.

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