Dana-Farber registers Phase 2 trial of Agenus drugs in early rectal cancer
A new Phase 2 study testing botensilimab plus balstilimab before surgery in early-stage rectal cancer was registered, with Agenus as a collaborator.
The week's notable filing is a newly listed trial combining two immunotherapy drugs in a small group of rectal cancer patients, sponsored by an academic center with Agenus as collaborator.
- "RECTIFY-1" (NCT07735624) is a Phase 2 study registered by Dana-Farber Cancer Institute, with Agenus Inc. and Gateway for Cancer Research listed as collaborators, and its status is recruiting. The trial evaluates neoadjuvant botensilimab in combination with balstilimab for patients whose rectal tumors are microsatellite stable and mismatch repair proficient, staged T1 to T2 with no nodal involvement on MRI, in people considered candidates for surgery without standard neoadjuvant therapy.1 The study plans to enroll 16 participants who will receive a single fixed dose of botensilimab 75 mg IV on day one, followed by balstilimab 240 mg IV every two weeks for up to six months.1 Its estimated start is September 2026, with primary completion estimated for January 1, 2027.
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