{"entity":{"id":"nct07735624","kind":"trial","name":"RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer","aka":["RECTIFY-1"],"tldr":"A phase 2 trial of botensilimab and balstilimab in colorectal cancer, run by Dana-Farber Cancer Institute, now recruiting.","summary":"RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer is a phase 2, interventional study registered as NCT07735624 by Dana-Farber Cancer Institute, with a registry enrolment figure of 16 participants, started 2026-09 and due to reach its primary completion in 2027-01-01. Interventions recorded: Botensilimab; Balstilimab. Conditions listed: Early Rectal Cancer; Stage I Rectal Cancer; Microsatellite Stable Rectal Carcinoma. Primary outcome: Complete response (cCR plus nCR with pCR at resection) within 6 months from initiation of therapy or nCR with pathologic complete response (pCR) with TES. Colorectal eligibility wording from the registry: \"* Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8th edition, 2017)\". Sites: United States. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT07735624","url":"https://clinicaltrials.gov/study/NCT07735624"}],"tags":["ctgov-ingest","colorectal-deep-dive"],"related":[],"cancers":["rectal-cancer","msi-high-colorectal"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["botensilimab","balstilimab"],"companies":["agenus"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07735624","phase":"2","setting":"A Phase 2 Study of the Safety and Efficacy of Neoadjuvant Botensilimab in Combination With Balstilimab in the Treatment of Microsatellite Stable / Mismatch Repair Proficient Early Rectal Cancer (RECTIFY-1)","sponsor":"Dana-Farber Cancer Institute","enrolled":16,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07735624/","neighbours":{"cancer":[{"id":"msi-high-colorectal","kind":"cancer","name":"Mismatch-repair deficient (MSI-high) colorectal cancer","route":"/cancers/msi-high-colorectal/"},{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"balstilimab","kind":"drug","name":"Balstilimab","route":"/drugs/balstilimab/"},{"id":"botensilimab","kind":"drug","name":"Botensilimab","route":"/drugs/botensilimab/"}],"company":[{"id":"agenus","kind":"company","name":"Agenus","route":"/companies/agenus/"}],"term":[{"id":"colorectal-trials-open-today","kind":"term","name":"Colorectal cancer trials open today (registry snapshot)","route":"/terms/colorectal-trials-open-today/"}]}}