OncoMatch/Clinical Trials/NCT07281716
Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC
Is NCT07281716 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Nadunolimab and Toripalimab for metastatic microsatellite stable colorectal carcinoma.
Treatment: Nadunolimab · Toripalimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine
progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and irinotecan
Must have received: oxaliplatin
progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and irinotecan
Must have received: irinotecan
progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and irinotecan
Cannot have received: chemotherapy
Exception: chemotherapy within 14 days from start of therapy
Patients who have had chemotherapy within 14 days from start of therapy
Cannot have received: immune checkpoint inhibitor
Exception: patients who discontinued prior immune checkpoint inhibitors due to immune-related adverse events are not eligible
Patients who discontinued prior immune checkpoint inhibitors due to immune-related adverse events are not eligible for enrollment
Lab requirements
Blood counts
adequate organ and marrow function
Kidney function
adequate organ and marrow function
Liver function
adequate organ and marrow function
adequate organ and marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Icahn School of Medicine at Mount Sinai · New York, New York
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