ROBBIN is a planned global, randomized, open-label Phase 3 study evaluating botensilimab plus balstilimab as neoadjuvant treatment for patients with previously untreated, resectable, high-risk Stage II or Stage III microsatellite-stable/mismatch repair-proficient colon cancer.

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Approximately 850 patients are expected to be randomized 1:1 to receive either:

Botensilimab plus balstilimab before surgery, followed by standard-of-care adjuvant chemotherapy or observation based on pathologic stage and clinical guidelines; or surgery followed by standard-of-care adjuvant chemotherapy or observation.

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The primary endpoint is event-free survival. Key secondary endpoints include overall survival, preservation of circulating tumor DNA clearance and quality of life. The study will also evaluate pathologic response, the relationship between pathologic response and longer-term outcomes, use of adjuvant chemotherapy and potential biomarkers.

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The ROBBIN study is planned and has not yet begun enrollment. Study details remain subject to final protocol completion and regulatory and ethics approvals.

This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.

This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.

The goal of this clinical trial is to test if the addition of botensilimab to standard chemotherapy improves the efficacy compared to just chemotherapy alone in participants with metastatic pancreatic cancer. One group of participants will only receive chemotherapy while a second group of participants will receive botensilimab and chemotherapy.