Clinical Trial

Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC

Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-04.
Status change: Not Yet Recruiting → Recruiting 2026-02-17
Trial Details
NCT Number NCT07281716
Lead Sponsor Dan Feng
Collaborators: Coherus Oncology, Inc., Cantargia AB
Conditions Metastatic Microsatellite Stable Colorectal Carcinoma
Enrollment 24 participants
Start Date 2025-12-01
Primary Completion 2028-12-15 (estimated)
Study Completion 2028-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-02-19