RecruitingPhase 1Phase 2NCT07281716

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

A Phase 1b/2 Study of Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC)


Sponsor

Dan Feng

Enrollment

24 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy drugs for people with metastatic colorectal cancer (cancer that has spread) that does not respond to immunotherapy on its own — specifically cancer that lacks a marker called MSI-H, which normally makes it more responsive to these drugs. **You may be eligible if...** - Your colorectal cancer has been confirmed by biopsy and is classified as non-MSI-H (microsatellite stable) - Your cancer has progressed or you could not tolerate standard chemotherapy regimens including fluoropyrimidines, oxaliplatin, and irinotecan - You have at least one tumor that can be measured on imaging (at least 10 mm) - You have at least one tumor site accessible for a biopsy - You are willing to provide blood samples at scheduled study visits **You may NOT be eligible if...** - You have not yet tried standard chemotherapy options - You are unable or unwilling to undergo biopsies or blood draws as required - You do not meet organ function or performance status requirements Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGNadunolimab

5 mg/kg intravenously (IV) every 3 weeks (Q3W)

DRUGToripalimab

240 mg IV every 3 weeks (Q3W)


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT07281716


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