Condition: Metastatic Microsatellite Stable Colorectal Carcinoma · Sponsor: Dan Feng
Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) and toripalimab (anti-PD-1) in patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer. Phase 1b will assess dose-limiting toxicity (DLT), while Phase 2 will evaluate objective response rate (ORR), including progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR). Exploratory analyses will investigate immunomodulatory effects through tumor and peripheral blood studies, and treatment will continue every 3 weeks for up to 1 year or until disease progression.
This description comes directly from the study's public registry record.
Jordan Cuevas · (212) 824-7945 · Jordan.Cuevas@mssm.edu
Rashmi Unawane · (212) 824-2385 · rashmi.unawane@mssm.edu
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| Icahn School of Medicine at Mount Sinai | New York, New York, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07281716