Actively Recruiting
Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC
Led by Dan Feng · Updated on 2026-02-19
24
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
D
Dan Feng
Lead Sponsor
C
Coherus Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a pathologically confirmed diagnosis of non-MSI-high/pMMR colorectal cancer.
- Patients must have progressed on or after standard chemotherapy including fluoropyrimidines, oxaliplatin, and irinotecan, or be intolerant to standard chemotherapy.
- Patients may have received anti-VEGF or anti-EGFR antibodies combined with chemotherapy if eligible.
- Patients must have at least one measurable target lesion at baseline of 10 mm or larger.
- Patients must be willing and able to provide blood samples as indicated.
- Patients must have at least one lesion suitable for core needle biopsy.
- Patients must be willing and able to have core needle biopsies if clinically feasible.
- Patients must be aged 18 years or older.
- Patients must have an ECOG Performance Status of 0-1, or >1 with a stable long-term disability not likely to affect therapy response.
- Women of child-bearing potential and men must agree to use adequate contraception during and for 4 months after study participation.
- Patients must be able to understand and willing to sign informed consent.
- Patients must have adequate organ and marrow function.
You will not qualify if you...
- Patients who have had chemotherapy within 14 days before starting therapy.
- Patients receiving any other investigational agents.
- Patients with uncontrolled illness such as active infection requiring antibiotics (except brief completed courses), symptomatic heart failure, unstable angina, or psychiatric/social conditions limiting study compliance.
- Patients who had major surgery within 4 weeks prior to first treatment dose.
- Pregnant or nursing patients.
- Patients who discontinued prior immune checkpoint inhibitors due to immune-related adverse events.
- Patients with immunodeficiency or on systemic immunosuppressive therapy within 7 days prior to treatment (except stable low-dose steroids).
- Patients with active autoimmune disease requiring systemic treatment in the past year.
- Patients with HIV with detectable viral load or unstable treatment, or low CD4+ T cell count.
- Patients with active hepatitis B or C infection unless controlled and monitored.
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
- Recent live vaccine within 28 days before starting treatment.
- Recent use of etanercept or TNF-alpha inhibitors within 28 days before treatment.
- Allergy or hypersensitivity to protein therapeutics.
- Patients unlikely to comply with all study visits or not in the best clinical interest according to the investigator.
- History of immune-related adverse events from prior immunotherapy not resolved to grade 0 or 1 (except stable endocrinopathies).
- History of interstitial lung disease or active noninfectious pneumonitis requiring immunosuppressive doses of glucocorticoids.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
J
Jordan Cuevas
CONTACT
R
Rashmi Unawane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here