Botensilimab and Balstilimab Optimization in Colorectal Cancer (NCT06268015) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Botensilimab and Balstilimab Optimization in Colorectal Cancer
United States16 participantsStarted 2024-11-18
Plain-language summary
This is a single-arm, interventional, pilot clinical trial. Fifteen evaluable patients will have tumor-informed ctDNA testing at baseline and start botensilimab and balstilimab treatment. They will receive botensilimab and balstilimab in 6-week cycles until progression, after which mFOLFOX6 and bevacizumab or panitumumab will be added to the regimen. Subjects will have safety testing at baseline and every two weeks while on study drug. Study treatment with botensilimab and balstilimab, mFOLFOX6, and bevacizumab or panitumumab will be continued until radiographic or clinical progression, toxicity, or patient withdrawal. Subjects will have one safety follow up visit 30 days after the last treatment and will be followed for survival every 12 weeks for up to 2 years.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants of any gender who are at least 18 years of age on the day of signing informed consent.
✓. Histologically confirmed metastatic and/or unresectable colorectal cancer without liver metastasis or known or suspected bone or brain metastases.
Exclusion criteria
✕. Microsatellite stable disease, as documented in the participant's medical record at the time of consent by the absence of MSI-H or dMMR result in an FDA-approved assay or an IVD offered as an LDT that includes microsatellite stability biomarker.
✕. Subject must be willing to provide fresh biopsy of tumor lesion. \*Note: Those who do not have a tumor lesion that is safe and amenable to biopsy may still be enrolled.
✕. ECOG performance status of 0 or 1.
✕. No prior systemic therapy for colon cancer.
✕. Measurable disease per RECIST v1.1.
✕. People of child-bearing potential must not be pregnant or breast feeding and meet at least one of the following conditions:
What they're measuring
1
Disease control rate based on iRECIST at second restaging scan
Timeframe: 24 weeks after screening
2
Proportion of subjects with a best overall response of complete response or partial response according to iRECIST
✕. A POCBP must agree to use a reliable method of contraception (refer to Section 6.7.1) during the treatment period and for at least 180 days after the last dose of study treatment.